Biosimilars/News

EMA recommends approval of bevacizumab Lytenava

Biosimilars/News | Posted 22/05/2024

On 21 March 2024, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorization (MA) for Outlook Therapeutics’ Lytenava (ONS-5010, bevacizumab gamma), intended for treatment of neovascular (wet) age-related macular degeneration (nAMD).

Three more biosimilar approvals in Canada in 2023

Biosimilars/News | Posted 14/05/2024

In Canada, three biosimilars were approved in late 2023. These are, Amgen’s Wezlana (ustekinumab), JAMP/Alvotech’s Jamteki (ustekinumab), and Formycon/Polpharma Biologics/Bioeq’s Ranopto (ranibizumab).

FDA approves interchangeable adalimumab biosimilar Simlandi

Biosimilars/News | Posted 11/03/2024

On 23 February 2024, the US Food and Drug Administration (FDA) approved Alvotech and Teva’s Simlandi (adalimumab-ryvk) injection as an interchangeable biosimilar to AbbVie’s Humira (adalimumab).

EMA recommends approval of first omalizumab biosimilar Omlyclo

Biosimilars/News | Posted 07/05/2024

On 21 March 2024, the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of marketing authorization for Omlyclo (omalizumab), Celltrion's biosimilar of the reference product Xolair.

China approves first denosumab copy biological Maiweijian

Biosimilars/News | Posted 16/04/2024

On 3 April 2024, China-based biopharmaceutical company Mabwell announced that their Maiweijian (denosumab) injection, developed by its wholly-owned subsidiary T-mab, obtained the marketing approval from China’s National Medical Products Administration (NMPA). This product is the first denosumab copy biologicalto receive marketing approval in China.

EMA recommends approval of first denosumab biosimilar Jubbonti and Wyost

Biosimilars/News | Posted 09/04/2024

On 21 March 2024, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for Sandoz’s medicinal products, Jubbonti and Wyost (denosumab), which are biosimilars of Amgen’s reference products Prolia and Xgeva, respectively.

First denosumab biosimilars approved in Canada and the US

Biosimilars/News | Posted 03/04/2024

The first and only denosumab biosimilars for osteoporosis and increasing bone mass were approved in Canada and the US in February and March 2024.

Clinical study advances for Alvotech golimumab and Dr Reddy’s rituximab biosimilars

Biosimilars/News | Posted 03/02/2023

In January 2023, Alvotech announced that it has initiated a pharmacokinetic study for AVT05, a biosimilar candidate to Simponi® and Simponi Aria® (golimumab). In addition, Dr Reddy’s Laboratories Ltd announced the successful completion of clinical studies of its proposed rituximab biosimilar candidate, DRL_RI. This is now ready for filing in markets such as the US and Europe.

Dr Reddy's launches bevacizumab biosimilar Versavo in the UK

Biosimilars/News | Posted 27/03/2024

On 19 March 2024, Dr Reddy’s Laboratories announced that it would be launching Versavo, a bevacizumab biosimilar, in the UK.

EMA recommends approval of ustekinumab biosimilar Pyzchiva

Biosimilars/News | Posted 22/03/2024

On 22 February 2024, the European Medicines Agency’s Committee for Medicinal Products for Human Use adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Pyzchiva (ustekinumab), a biosimilar of reference product Stelara.

EC approval of ranibizumab biosimilar Rimmyrah

Biosimilars/News | Posted 07/03/2024

The European Commission (EC) granted marketing authorization for ranibizumab biosimilar Rimmyrah on 5 January 2024. The biosimilar was developed by Qilu Pharma.

FDA BLA updates from Celltrion and Accord

Biosimilars/News | Posted 29/02/2024

In January 2024, Celltrion submitted a Biologics License Application (BLA) to the US Food and Drug Administration (FDA) for CT-P47, a biosimilar candidate of the reference product Actemra ( tocilizumab). In addition, Accord BioPharma, announced that the FDA accepted its BLA for DMB-311, a biosimilar to Stelara (ustekinumab), approved for the treatment of plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis.

FDA approves pegfilgrastim biosimilar Udenyca OnBody autoinjector

Biosimilars/News | Posted 06/02/2024

On 26 December 2023, Coherus BioSciences announced the US Food and Drug Administration’s (FDA) approval of Udenyca OnBody, an on-body injector (OBI) presentation of Udenyca (pegfilgrastim-cbqv), a pegfilgrastim biosimilar administered the day after chemotherapy to decrease the incidence of infection as manifested by febrile neutropenia.

FDA approves bevacizumab biosimilar Avzivi

Biosimilars/News | Posted 30/01/2024

On 6 December 2023, the US Food and Drug Administration (FDA) approved China–based manufacturer Bio-Thera Solutions’ bevacizumab biosimilar (BAT1706), Avzivi (bevacizumab-tnjn). This product will be marketed globally by Sandoz.

FDA approves first tocilizumab biosimilar Tofidence

Biosimilars/News | Posted 17/10/2023

On 29 September 2023, the US Food and Drug Administration approved Tofidence (tocilizumab-bavi) as the first biosimilar to Actemra (tocilizumab). Tofidence is first-of-its-kind biosimilar tocilizumab to receive approval in the US.

EC approval of trastuzumab biosimilar Herwenda

Biosimilars/News | Posted 23/01/2024

The European Commission (EC) granted marketing authorization for trastuzumab biosimilar Herwenda on 15 November 2023. The biosimilar of Herwenda is developed by EirGenix, Inc.

EC approval of first ustekinumab biosimilar Uzpruvo

Biosimilars/News | Posted 16/01/2024

On 5 January 2024, the European Commission (EC) granted marketing authorization for the first ustekinumab biosimilar Uzpruvo (AVT04). The biosimilar of Uzpruvo is developed by Iceland-based biosimilar manufacturer Alvotech.

Alvotech: rejection AVT02 in the US and new partnerships with Prolifarma and Advanz Pharma

Biosimilars/News | Posted 03/08/2023

The US Food and Drug Administration (FDA) rejected Alvotech’s biologicals licence application (BLA) for their biosimilar adalimumab AVT02 in June 2023. Alvotech has also formed new partnerships with Prolifarma and Advanz Pharma for proposed biosimilars to Eylea (aflibercept) and Xolair (omalizumab), respectively.

Rinvoq approved to treat Crohn’s disease in Europe

Biosimilars/News | Posted 27/04/2023

On 17 April 2022, AbbVie announced that its Rinvoq (upadacitinib) had received European Commission (EC) approval. It is the first and only oral Janus Kinase (JAK) inhibitor approved to treat moderately to severely active Crohn's disease in adult patients. Rinvoq has the potential to rival AbbVie’s own blockbuster drug, Humira (adalimumab) and its biosimilars for inflammatory autoimmune conditions [1].

EMA recommends approval of ranibizumab biosimilar Rimmyrah

Biosimilars/News | Posted 12/12/2023

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use announced on 9 November 2023 that it had recommended granting of marketing authorization for Rimmyrah (ranibizumab), a biosimilar that references ophthalmology drug, Lucentis.

FDA approves Zymfentra and advances for Yuflyma in the US

Biosimilars/News | Posted 05/12/2023

On 23 October 2023, the US Food and Drug Administration (FDA) approved Celltrion’s Zymfentra (infliximab-dyyb) biosimilar as the first subcutaneous (SC) formulation of infliximab. In addition, Celltrion USA signed a contract with Ventegra to add Yuflyma (adalimumab-aaty) as a preferred formulary product in both public and private insurance markets.

EC approval of natalizumab, aflibercept and tocilizumab biosimilars

Biosimilars/News | Posted 28/11/2023

In September 2023, the European Commission (EC) granted marketing authorization for the biosimilars of Tyruko (natalizumab), Yesafili (aflibercept), and Tyenne (tocilizumab).

EMA recommends approval of first ustekinumab biosimilar Uzpruvo

Biosimilars/News | Posted 14/11/2023

On 9 November 2023, the European Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Uzpruvo (ustekinumab), a biosimilar of reference product Stelara, intended for the treatment plaque psoriasis, including paediatric plaque psoriasis, psoriatic arthritis and Crohn’s disease in adults.

FDA approves first interchangeable ustekinumab biosimilar Wezlana

Biosimilars/News | Posted 07/11/2023

On 31 October 2023, the US Food and Drug Administration (FDA) approved Wezlana (ustekinumab-auub) as a biosimilar to and interchangeable with Stelara (ustekinumab) for multiple inflammatory diseases.

Alvotech biosimilars: FDA ustekinumab application rejection; adalimumab interchangeability designation re-submission

Biosimilars/News | Posted 31/10/2023

In October 2023, Iceland-based biosimilar manufacturer Alvotech, announced that the US Food and Drug Administration (FDA) has issued a complete response letter (CRL) for Alvotech’s Biologics License Application (BLA) for AVT04, a biosimilar candidate to Stelara (ustekinumab). As such, the application was not approved. This follows Alvotech’s September 2023 resubmission of a BLA for their high-concentration biosimilar formulation to AbbVie’s blockbuster arthritis treatment Humira (adalimumab), AVT02 [1], following receipt of a similar CRL.

Japanese approval for first ustekinumab biosimilar

Biosimilars/News | Posted 24/10/2023

Iceland-based biosimilar manufacturer Alvotech announced on 25 September 2023 that its commercialization partner in Japan, Fuji Pharma Co Ltd (Fuji) had received marketing approval from Japan’s medicines regulatory agency, the Pharmaceuticals and Medical Devices Agency (PMDA), for its ustekinumab biosimilar AVT04 in Japan.

FDA grants interchangeable designation to adalimumab biosimilar Abrilada

Biosimilars/News | Posted 09/10/2023

US-based pharma giant Pfizer announced on 5 October 2023 that the US Food and Drug Administration (FDA) has designated Abrilada (adalimumab-afzb) as an interchangeable biosimilar to Humira (adalimumab). The interchangeable designation applies to all approved indications of Abrilada, including certain patients with rheumatoid arthritis (RA), juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, ulcerative colitis, plaque psoriasis, hidradenitis suppurativa and uveitis.

EMA recommends approval of trastuzumab biosimilar Herwenda

Biosimilars/News | Posted 03/10/2023

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 15 September 2023 that it had recommended granting of marketing authorization for the trastuzumab biosimilar Herwenda, 150 mg, for intravenous use.

FDA approves first natalizumab biosimilar Tyruko for MS

Biosimilars/News | Posted 14/09/2023

On 24 August 2023, the US Food and Drug Administration approved Tyruko (natalizumab-sztn) as the first biosimilar to Tysabri (natalizumab) for the treatment of adults with relapsing forms of multiple sclerosis (MS). Tyruko is first-of-its-kind biosimilar natalizumab to receive approval in the US.

EMA recommends approval of first natalizumab biosimilar Tyruko for MS

Biosimilars/News | Posted 24/08/2023

On 20 July 2023, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of marketing authorisation for the medicinal product Tyruko (natalizumab), a biosimilar of reference product Tysabri, intended for the treatment of multiple sclerosis (MS).

China approves bevacizumab copy biological Ankeda

Biosimilars/News | Posted 31/01/2020

China’s National Medical Products Administration (NMPA), formerly the China Food and Drug Administration (CFDA), announced on 9 December 2019 that it had approved Ankeda, a bevacizumab copy biological.

EMA recommends approval of first aflibercept and tocilizumab biosimilars

Biosimilars/News | Posted 10/08/2023

On 20 July 2023, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of marketing authorisation for the medicinal product Yesafili (aflibercept), an ophthalmology biosimilar, and Tyenne (tocilizumab), an immunosuppressant used largely for treatment of arthritis.

Coherus: lowest price adalimumab biosimilars announced

Biosimilars/News | Posted 28/07/2023

Coherus BioSciences has announced that it will launch Yusimry, its adalimumab biosimilar, at the lowest price announced to date in the US.

Celltrion: advances for Yuflyma and Vegzelma biosimilars

Biosimilars/News | Posted 20/06/2023

In the first half of 2023, South-Korea based Celltrion Biologics announced the approval of their Yuflyma (adalimumab-aaty) biosimilar in the US, the winning of a bid to supply Italy and Belgium with bevacizumab biosimilar Vegzelma.

Alkem launches first cetuximab similar biologic in India

Biosimilars/News | Posted 13/06/2023

In May 2023, Alkem Oncology announced the launch of Cetuxa, the fist similar biologic of cetuximab used in the treatment of head and neck cancer. The cetuximab originator was developed by Merck and is sold under the brand name Erbitux.

EMA recommends approval of eculizumab biosimilar Epysqli

Biosimilars/News | Posted 30/05/2023

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 31 March 2023 that it had adopted a positive opinion for Epysqli.

Advances for STADA-Xbrane’s Ximluci in Europe, the UK and the US

Biosimilars/News | Posted 04/05/2023

The STADA and Xbrane co-developed Ximluci, ranibizumab biosimilar is to launch in Europe and will now also be available on the UK’s National Health Service (NHS). In addition, the partners have submitted their Biologics License Application (BLA) to the US Food and Drug Administration (FDA).

US and EC approvals for Hyrimoz, US approval for Udenyca autoinjector

Biosimilars/News | Posted 14/04/2023

In March 2023, the US Food and Drug Administration (FDA) approved Sandoz’s Hyrimoz biosimilar, a citrate-free high-concentration formulation (HCF) of adalimumab, as well as Coherus Biosciences’ (Coherus) innovative single-dose, prefilled autoinjector presentation of Udenyca (pegfilgrastim-cbqv).

Biosimilar launches in Canada and US: Byooviz and Stimufend

Biosimilars/News | Posted 31/03/2023

In Canada, Biogen announced that their Byooviz (ranibizumab) injection, a biosimilar of Lucentis, is available as of March 2023. In the preceding month, Fresenius Kabi launched Stimufend (pegfilgrastim-fpgk), a biosimilar of Amgen’s Neulasta, in the US.

EMA recommends approval of eculizumab biosimilar Bekemv

Biosimilars/News | Posted 23/03/2023

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 24 February 2023 that it had recommended granting of marketing authorization for the eculizumab biosimilar Bekemv.

China approves tocilizumab copy biological BAT1806

Biosimilars/News | Posted 16/03/2023

In January 2023, Bio-Thera Solutions announced that the China National Medical Products Administration (NMPA) approved BAT1806, a biosimilar of Actemra (tocilizumab), in China. This is the world’s first tocilizumab copy biological/biosimilar to be approved.

FDA accepts application for denosumab biosimilar GP2411

Biosimilars/News | Posted 09/03/2023

Sandoz, the generics division of Novartis, announced on 6 February 2023 that the US Food and Drug Administration (FDA) has accepted its Biologics License Application (BLA) for a proposed denosumab biosimilar (GP2411).

EMA accepts application for ustekinumab biosimilar AVT04

Biosimilars/News | Posted 03/03/2023

Alvotech announced on 9 February 2023 that the European Medicines Agency (EMA) has accepted a Marketing Authorization Application for AVT04, their proposed biosimilar to Stelara (ustekinumab).

Ranibizumab biosimilar Ximluci and Amelivu to launch in the UK and South Korea

Biosimilars/News | Posted 24/02/2023

STADA and Xbrane Biopharma have announced that the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has granted a marketing authorization for Ximluci, a biosimilar referencing ophthalmology drug, Lucentis (ranibizumab). In addition, Samsung Bioepis and Samil Pharmaceuticals will launch their biosimilar of Lucentis, Amelivu, in South Korea.

New indication for Cosentyx (secukinumab) biological: hidradenitis suppurativa

Biosimilars/News | Posted 19/05/2023

The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use adopted a positive opinion on 26 April 2023 recommending Novartis' Cosentyx (secukinumab) to treat active moderate to severe hidradenitis suppurativa (HS) in adults.

Advances for Henlius’ trastuzumab and bevacizumab biosimilars in the US

Biosimilars/News | Posted 20/04/2023

The US Food and Drug Administration (FDA) accepted Henlius' application for HLX02 (biosimilar trastuzumab for injection). Meanwhile, Henlius' multicentre phase III clinical trial (NCT04740671) of HLX04-O (biosimilar bevacizumab) for wet age-related macular degeneration (wAMD) commenced in the US with the first patient dosed.

First African developed biosimilar adalimumab starts phase I trial in Germany

Biosimilars/News | Posted 06/04/2023

A phase I clinical trial of Minapharm Pharmaceuticals’ first African developed adalimumab biosimilar, Adessia, was initiated on 24 February 2023 in Germany with results to be expected at the end of 2023.

Bevacizumab biosimilar Vegzelma approved and Aybintio launched in Canada

Biosimilars/News | Posted 10/02/2023

The bevacizumab biosimilar Vegzelma produced by Celltrion received full label approval from Canada’s drug regulator, Health Canada (HC), on 3 January 2023. Back in November 2022, bevacizumab biosimilar Aybintio by Samsung Bioepis had been launched in Canada by Organon, offering a more affordable treatment for Canadian patients suffering from certain types of aggressive cancer.

Advances for Alvotech’s partnerships in Japan, Canada and Switzerland

Biosimilars/News | Posted 18/11/2022

In October 2022, Alvotech announced new advances with partners Fuji Pharma in Japan and JAMP in Canada. In addition, in September 2022, with its partner STADA, Alvotech announced the launch of Hukyndra, its high-concentration, low-volume, citrate-free formulation, biosimilar to Humira (adalimumab), in Switzerland.

Progress for Lucentis (ranibizumab) biosimilars in Europe and the US

Biosimilars/News | Posted 28/10/2022

On 16 September 2022, Partners Stada Arzneimittel and Xbrane Biopharma announced that the European Medicines Agency’S (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for Ximluci, a biosimilar candidate referencing Lucentis (ranibizumab). In addition, on 19 September 2022 in the US, Coherus BioSciences announced that from 3 October 2022, another ranibizumab biosimilar, Cimerli (ranibizumab-eqrn) will be commercially available.

Advances for adalimumab biosimilars in Saudi Arabia, Europe and Canada

Biosimilars/News | Posted 17/02/2023

In January 2023, Alvotech-Bioventure, Sandoz and Samsung Bioepis announced advances for their adalimumab biosimilars in Saudi Arabia, Europe and Canada, respectively.

New insulin glargine and potential adalimumab interchangeable biosimilars

Biosimilars/News | Posted 27/01/2023

The US Food and Drug Administration (FDA) awarded Eli Lilly’s Rezvoglar, an insulin glargine biosimilar, the interchangeable designation in late 2022. This means that in the US, Rezvoglar can now be substituted at the pharmacy level for the originator, Sanofi’s Lantus, without a doctor’s prescription, provided state pharmacy law permits the switch. In addition, a study revealed that Pfizer’s adalimumab biosimilar may also soon achieve this status.

Biosimilar advances for Alvotech-Teva and setback for Biocon Biologics

Biosimilars/News | Posted 20/01/2023

Alvotech and Teva Pharmaceuticals announced in January 2023, that the US Food and Drug Administration (FDA) accepted for review a Biologics License Application (BLA) for AVT04, Alvotech’s proposed biosimilar to Stelara® (ustekinumab). Meanwhile, Biocon Biologics received a complete response letter (CRL) from FDAregarding its application for an insulin aspart biosimilar (filed by its partner Viatris).

Advances for Bio-Thera’s secukinumab and mepolizumab copy biologicals

Biosimilars/News | Posted 13/01/2023

China’s Bio-Thera Solutions announced in November 2022 that dosing has begun in a phase III clinical study for BAT2306, a proposed copy biological of arthritis anti-inflammatory treatment, Cosentyx (secukinumab). In addition, the company also recently announced a phase I clinical study to compare the pharmacokinetics and safety of BAT2606, a proposed copy biological of asthma treatment, Nucala (mepolizumab), to US-sourced and EU-sourced reference product in normal healthy volunteers.

FDA and EMA file acceptance of Biogen’s tocilizumab biosimilar

Biosimilars/News | Posted 12/12/2022

Biogen announced on 9 December 2022 that the US Food and Drug Administration (FDA) has accepted for review the abbreviated Biologics License Application (BLA) for BIIB800, a biosimilar candidate referencing Roche’s Actemra/RoActemra (tocilizumab); and on 30 September 2022 that the European Medicines Agency (EMA) has accepted the Marketing Authorization Application for BIIB800.

Canada approves etanercept biosimilar Rymti

Biosimilars/News | Posted 01/12/2022

The etanercept biosimilar Rymti, produced by Lupin, received approval from Canada’s drug regulator, Health Canada (HC), on 13 September 2022, for all indications of the reference product Enbrel. This is the third etanercept biosimilar to receive approval in Canada [1].

Australia and EU: Alvotech Humira and Stada Lucentis biosimilars approved

Biosimilars/News | Posted 25/11/2022

In November 2022, Alvotech announced that the Therapeutic Goods Administration (TGA) of Australia has granted marketing authorization for its a high-concentration low-volume adalimumab, AVT02, a biosimilar referencing Humira and marketed by their partner, Cipla Australia. In addition, Stada Arzneimittel and Xbrane Biopharma announced that the European Commission granted marketing authorization for their Ximluci (ranibizumab), a biosimilar candidate referencing Lucentis.

Bevacizumab biosimilar approvals and launch in Japan and USA

Biosimilars/News | Posted 21/10/2022

On 27 and 28 September 2022, Celltrion announced that its oncology biosimilar bevacizumab, Vegzelma, has been approved in Japan and the US. In October 2022, Amneal Pharmaceuticals, also announced the launch of Alymsys (bevacizumab-maly) in the US.

Forwards for Formycon’s Keytruda and backwards for Prestige’s Herceptin

Biosimilars/News | Posted 14/10/2022

On 19 September 2022, Formycon announced details of a project to produce a biosimilar of Keytruda (pembrolizumab). This followed news that, on 16September 2022, Prestige Biopharma withdrew the Marketing Authorization Application (MAA) for their Herceptin Biosimilar, Tuznue, submitted to the European Medicines Agency (EMA).

FDA approves biosimilar pegfilgrastim Stimufend

Biosimilars/News | Posted 06/10/2022

On 6 September 2022, Fresenius Kabi announced that they had received approval from the US Food and Drug Administration (FDA) for their pegfilgrastim biosimilar, Stimufend (pegfilgrastim-fpgk).

EC approves bevacizumab biosimilar Vegzelma

Biosimilars/News | Posted 23/09/2022

On 18 August 2022, South Korea-based biologicals specialist Celltrion announced that its bevacizumab biosimilar, Vegzelma (CT-P16), had received European Commission (EC) approval.

FDA accepts application for high concentration adalimumab biosimilar

Biosimilars/News | Posted 16/09/2022

Sandoz, the generics division of Novartis, announced on 21 July 2022 that the US Food and Drug Administration (FDA) had accepted the supplemental biologics license application for the high concentration formulation (HCF) of its adalimumab biosimilar Hyrimoz (GP2017) (adalimumab-adaz).

EC approves ranibizumab biosimilar Ranivisio

Biosimilars/News | Posted 16/09/2022

On 29 August 2022, the ranibizumab biosimilar Ranivisio (FYB201), developed by Bioeq – a joint venture between Formycon and Polpharma Biologics, was granted marketing approval by the European Commission (EC).

Applications for natalizumab biosimilars accepted by FDA and EMA

Biosimilars/News | Posted 09/09/2022

Applications for natalizumab biosimilars made by Sandoz (the generics division of Novartis) and Polpharma Biologics (Polpharma) have been accepted by the US Food and Drug Administration (FDA) and European Medicines Agency (EMA).

FDA accepts application for tocilizumab biosimilar

Biosimilars/News | Posted 02/09/2022

Fresenius Kabi, the generics unit of German healthcare giant Fresenius, announced on 1 August 2022 that the US Food and Drug Administration (FDA) had accepted the application for their proposed tocilizumab biosimilar (MSB11456).

FDA approves first interchangeable ranibizumab biosimilar

Biosimilars/News | Posted 26/08/2022

Polpharma Biologics, Formycon and Bioeq jointly announced on 2 August 2022 that they had received approval from the US Food and Drug Administration (FDA) for their ranibizumab biosimilar (CHS-201/FYB201).

Innovent-Etana bevacizumab biosimilar approved in Indonesia

Biosimilars/News | Posted 29/07/2022

Innovent announced the approval of its bevacizumab biosimilar in Indonesia, that was developed in partnership with PT Etana Biotechnologies Indonesia.

Ranibizumab biosimilar, FYB201, receives EMA recommendation

Biosimilars/News | Posted 22/07/2022

Formycon’s ranibizumab biosimilar, FYB201, has received a positive opinion from the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP).

New data on infliximab and adalimumab biosimilars at EULAR 2022

Biosimilars/News | Posted 15/07/2022

The Annual European Congress of Rheumatology (EULAR 2022) was held at the beginning of June 2022. This platform was used to announce the results of a study that showed that, in patients with rheumatoid arthritis, statistically greater improvements in clinical outcomes with subcutaneous infliximab, compared to intravenous infliximab. In addition, Samsung Bioepis announced new data on their established adalimumab biosimilar Imraldi (Hadlima outside Europe).

EMA accepts application for high concentration adalimumab biosimilar

Biosimilars/News | Posted 08/07/2022

Sandoz, the generics division of Novartis, announced on 17 June 2022 that the European Medicines Agency (EMA) has accepted the application for its high concentration formulation (HCF) of its adalimumab biosimilar Hyrimoz (GP2017).

EMA recommends approval of bevacizumab biosimilar Vegzelma

Biosimilars/News | Posted 01/07/2022

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 24 June 2022 that it had recommended granting marketing authorization for the bevacizumab biosimilar Vegzelma.

FDA approves pegfilgrastim and rituximab biosimilars

Biosimilars/News | Posted 24/06/2022

The US Food and Drug Administration (FDA) has approved the pegfilgrastim biosimilar Fylnetra (pegfilgrastim-pbbk) and the rituximab biosimilar Riabni (rituximab-arrx).

Byooviz: first ophthalmology biosimilar launches in US

Biosimilars/News | Posted 17/06/2022

Biogen and Samsung Bioepis have launched Byooviz (ranibizumab-nuna) on the US market as the first ophthalmology biosimilar. It references Roche’s (Genentech’s) blockbuster therapy, Lucentis.

Biocon: cancer biosimilar launch in Canada and US$90 million Malaysia deal

Biosimilars/News | Posted 10/06/2022

In May 2022, Biocon Biologics launched a bevacizumab biosimilar co-developed with Viatris (formerly Mylan), in Canada; and in April 2022, Biocon was awarded a three-year contract, worth US$90 million, by Malaysia's Ministry of Health

Canada approves five biosimilars in last seven months

Biosimilars/News | Posted 03/06/2022

Since November 2021, Canada’s drug regulator, Health Canada, has approved no less than five biosimilars for the treatment of diabetes, cancer, osteoporosis and autoimmune conditions.

Lucentis biosimilars approved in the UK and Korea

Biosimilars/News | Posted 27/05/2022

The United Kingdom’s (UK) Medicines and Healthcare products Regulatory Agency (MHRA) and South Korea’s Ministry of Food and Drug Safety have approved biosimilar versions of Genentech’s ophthalmology drug, Lucentis (ranibizumab).

New adalimumab biosimilars prepare to launch in Canada, US and Europe

Biosimilars/News | Posted 16/05/2022

Several new adalimumab biosimilar products are preparing to launch in Canada, the US and Europe, from manufacturers including BIOJAMP, Alvotech and Celltrion.

FDA approves Amneal’s bevacizumab biosimilar

Biosimilars/News | Posted 06/05/2022

The US Food and Drug Administration (FDA) has approved Amneal Pharmaceuticals’ (Amneal) bevacizumab biosimilar, Alymsys, the third bevacizumab biosimilar to be approved in the US.

Europe: positive opinion for Inpremzia and Truvelog Mix 30 and Stimufend authorized

Biosimilars/News | Posted 29/04/2022

On 28 March 2022, the European Commission (EC) has granted marketing authorization for Fresenius Kabi's oncology biosimilar, Stimufend (pegfilgrastim); and the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 24 February 2022 that it had recommended granting of marketing authorization for an insulin aspart biosimilar and an insulin human (rDNA) biosimilar.

FDA approves Kashiv Biosciences’ filgrastim biosimilar

Biosimilars/News | Posted 15/04/2022

The US Food and Drug Administration (FDA) has approved a filgrastim biosimilar produced by India-based Kashiv Biosciences. The biosimilar will be marketed under the trade name Releuko (filgrastim-ayow).

Celltrion updates on Remsima and Yuflyma

Biosimilars/News | Posted 08/04/2022

South Korean biotechnology company Celltrion announced two new data sets on the subcutaneous formulation Remsima (infliximab) in a number of conditions in March 2022. This followed the February 2022 announcement that the high-concentration version of Celltrion’s autoimmune disease biosimilar Yuflyma (adalimumab) has received approval from the European Commission.

Henlius makes deal with Getz Pharma for adalimumab copy biological

Biosimilars/News | Posted 01/04/2022

China-based drugmaker Shanghai Henlius Biotech (Henlius) announced on 23 February 2022 that it had entered into a licensing and supply agreement with Pakistan-based Getz Pharma for its adalimumab copy biological, Handa Yuan (汉达远; HLX03).

Canada approves ranibizumab biosimilar Byooviz

Biosimilars/News | Posted 25/03/2022

The ranibizumab biosimilar Byooviz (SB11), produced by Samsung Bioepis and commercialized by Biogen, received approval from Canada’s drug regulator, Health Canada, on 8 March 2022. This is the first ranibizumab biosimilar to receive approval in Canada.

FDA accepts application for interchangeability of adalimumab biosimilar Abrilada

Biosimilars/News | Posted 18/03/2022

US-based pharma giant Pfizer announced on 25 February 2022 that the US Food and Drug Administration (FDA) had accepted for review the Prior Approval Supplement (PAS) to the Biologics License Application (BLA) for Abrilada (adalimumab-afzb) as an interchangeable biosimilar to Humira (adalimumab).

Generium launches omalizumab (Xolair) non-originator in Russia

Biosimilars/News | Posted 11/03/2022

Moscow’s Generium has launched a non-originator biological of omalizumab (Xolair) on the Russian market, the third of Generium’s products using Selexis’ SUREtechnology Platform to reach the market.

EMA recommends approval of teriparatide and pegfilgrastim biosimilars

Biosimilars/News | Posted 18/02/2022

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 28 January 2022 that it had recommended granting of marketing authorization for the teriparatide biosimilar Sondelbay and the pegfilgrastim biosimilar Stimufend.

Lupin forms partnership to market pegfilgrastim biosimilar in Brazil

Biosimilars/News | Posted 11/02/2022

Indian multinational pharmaceutical company Lupin Ltd (Lupin) has signed an agreement with Brazilian firm Biomm SA to distribute and market a pegfilgrastim biosimilar in Brazil. In related news, Indian firm Gland Pharma has announced plans to enter the market for biosimilar manufacturing.

Applications for adalimumab and trastuzumab biosimilars submitted to FDA

Biosimilars/News | Posted 04/02/2022

Korea-based Samsung Bioepis and partner US-based Organon announced on 5 January 2022 that the US Food and Drug Administration (FDA) had accepted the application for their proposed citrate-free, high-concentration (100 mg/mL) adalimumab biosimilar (SB5). A low-concentration formulation of SB5, Hadlima (adalimumab-bwwd), was approved in the US in July 2019 [1].

FDA approves adalimumab and insulin glargine biosimilars Yusimry and Rezvoglar

Biosimilars/News | Posted 28/01/2022

The US Food and Drug Administration (FDA) has approved the adalimumab biosimilar Yusimry (adalimumab-aqvh) and the insulin glargine biosimilar Rezvoglar (insulin glargine-aglr) [1].

Canada approves adalimumab biosimilars Simlandi and Yuflyma

Biosimilars/News | Posted 21/01/2022

Canada’s drug regulator, Health Canada, has approved the adalimumab biosimilars Simlandi (AVT02) and Yuflyma (CT-P17).

Canada approves filgrastim biosimilar Nypozi

Biosimilars/News | Posted 14/01/2022

Canada’s drug regulator, Health Canada, has approved the filgrastim biosimilar Nypozi (TX01). The drug can be used to treat neutropenia (a lack of white blood cells) in cancer patients.

Etanercept biosimilars delayed until 2029 in US

Biosimilars/News | Posted 14/01/2022

Yet another patent challenge to Amgen’s originator etanercept, Enbrel, has been denied in the US.

Positive phase III results for omalizumab copy biological

Biosimilars/News | Posted 27/05/2016

US-based biopharmaceutical company Sorrento Therapeutics (Sorrento) announced on 16 May 2016 that its partner, MabTech had successfully completed a combined phase II and III clinical trial in China for STI-004, a copy biological for omalizumab (Xolair). STI 004 met its primary endpoint in a multicentre, randomized, double-blind, placebo-controlled, clinical study.

New Zealand announces funding for adalimumab biosimilar

Biosimilars/News | Posted 17/12/2021

New Zealand has announced that, in order to widen access to adalimumab, it will now fund the adalimumab biosimilar Amgevita.

China approves three bevacizumab copy biologicals

Biosimilars/News | Posted 10/12/2021

China’s National Medical Products Administration (NMPA), formerly the China Food and Drug Administration (CFDA) has approved three bevacizumab.

Celltrion seeks approval for bevacizumab biosimilar in Europe, US and Korea

Biosimilars/News | Posted 03/12/2021

South Korean biotechnology company Celltrion announced in October 2021 that it had applied for marketing approval for its candidate bevacizumab biosimilar (CT P16) in Europe, Korea and the US.

Adalimumab biosimilar launched in Japan

Biosimilars/News | Posted 03/12/2021

Japan-based Mochida Pharmaceutical (Mochida) announced on 25 November 2021 that its adalimumab biosimilar had been launched in Japan following the listing of the drug on the National Health Insurance (NHI).

Australian and Indian approval for teriparatide products

Biosimilars/News | Posted 02/04/2021

Australia’s drug regulatory agency, the Therapeutic Goods Administration (TGA), has approved a teriparatide biosimilar and the Drug Controller General of India (DCGI) has approved a teriparatide ‘similar biologic’.

China accepts Bio-Thera’s application for tocilizumab copy biological BAT1806

Biosimilars/News | Posted 26/11/2021

China’s National Medical Products Administration (NMPA) has accepted a marketing authorization application for Bio-Thera Solutions’ (Bio-Thera) copy biological of tocilizumab, an immunosuppressant used in the treatment of arthritis.

Australia’s PBAC recommends unrestricted benefit listing for rituximab biosimilars

Biosimilars/News | Posted 19/11/2021

Australia’s Pharmaceutical Benefits Advisory Committee (PBAC) has recommended that the Pharmaceutical Benefits Scheme (PBS) listing for the rituximab biosimilars Riximyo and Truxima be changed to ‘Unrestricted Benefit listings’.

Canada approves filgrastim and insulin aspart biosimilars Nypozi and Kirsty

Biosimilars/News | Posted 12/11/2021

Canada’s drug regulator, Health Canada, has approved the filgrastim and insulin aspart biosimilars Nypozi and Kirsty.

China approves Factor VIII copy biological Anjian

Biosimilars/News | Posted 05/11/2021

China-based drugmaker SinoCellTech (formerly known as Shenzhou Cell) announced on 23 July 2021 that China’s National Medical Products Administration (NMPA), formerly the China Food and Drug Administration (CFDA), had approved its recombinant human coagulation factor VIII (susoctocog alfa) copy biological Anjian.

FDA approves adalimumab biosimilar Cyltezo as interchangeable

Biosimilars/News | Posted 29/10/2021

The US Food and Drug Administration (FDA) has approved the first interchangeable adalimumab biosimilar. This is the second interchangeable biosimilar to gain FDA approval in the US and follows the landmark decision to approve an interchangeable insulin glargine biosimilar in July 2021 [1].

Bio-Thera and Samsung Bioepis start clinical trials for ustekinumab biosimilars

Biosimilars/News | Posted 29/10/2021

China’s Bio-Thera Solutions and South Korea’s Samsung Bioepis have begun phase III clinical trials for biosimilars to Janssen’s blockbuster anti-inflammatory drug Stelara (ustekinumab).

Canada approves adalimumab and bevacizumab biosimilars

Biosimilars/News | Posted 22/10/2021

Canada’s drug regulator, Health Canada, has approved the bevacizumab biosimilar Bambevi and the adalimumab biosimilar Abrilada (PF-06410293).

Bioeq submits application for ranibizumab biosimilar to FDA

Biosimilars/News | Posted 15/10/2021

A ranibizumab biosimilar developed by Swiss biotechnology company Bioeq AG (Bioeq) has been successfully submitted to the US Food and Drug Administration (FDA) for review.

CuraTeQ submits application to EMA for pegfilgrastim biosimilar

Biosimilars/News | Posted 08/10/2021

India-based generics maker Aurobindo Pharma (Aurobindo) announced on 22 September 2021 that its subsidiary CuraTeQ Biologics (CuraTeQ) had submitted an application to the European Medicines Agency (EMA) for its pegfilgrastim biosimilar, BP14.

EMA recommends approval of two adalimumab biosimilars

Biosimilars/News | Posted 01/10/2021

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 17 September 2021 that it had recommended granting marketing authorization for the adalimumab biosimilars Hukyndra and Libmyris.

EC and FDA approval for first ranibizumab biosimilar Byooviz

Biosimilars/News | Posted 24/09/2021

On 18 August 2021, the ranibizumab biosimilar Byooviz (SB11), produced by Samsung Bioepis and commercialized by Biogen, received European Commission (EC) approval. Then on 20 September 2021 the pair announced that Byooviz had also received approval from the US Food and Drug Administration (FDA). This is the first ranibizumab biosimilar, or indeed ophthalmology biosimilar, to receive approval in either Europe or the US.

EC approval for insulin aspart biosimilar Kixelle

Biosimilars/News | Posted 26/03/2021

The European Commission (EC) has granted marketing authorization for the insulin aspart biosimilar Kixelle (MYL 1601D), developed by US-based drugmaker Mylan (now Viatris) and India-based biologicals specialist Biocon.

Canada approves insulin aspart biosimilar Trurapi

Biosimilars/News | Posted 12/02/2021

Canada’s drug regulator, Health Canada, has approved the insulin aspart biosimilar Trurapi.

EMA recommends approval of insulin aspart biosimilar Kixelle

Biosimilars/News | Posted 29/01/2021

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 11 December 2020 that it had recommended granting of marketing authorization for an insulin aspart biosimilar.

Bevacizumab biosimilars launched in Spain and Korea

Biosimilars/News | Posted 17/09/2021

New bevacizumab biosimilars have been launched in Spain and South Korea.

Mabpharm gains approval for infliximab biobetter in China

Biosimilars/News | Posted 10/09/2021

US-based biopharmaceutical company Sorrento Therapeutics (Sorrento) announced on 20 July 2021 that its partner, China-based Mabpharm, had received marketing approval from China’s National Medical Products Administration (NMPA), formerly the China Food and Drug Administration (CFDA), for its infliximab ‘biobetter’ (CMAB008).

Formycon/Bioeq submit European marketing authorization for ranibizumab biosimilar

Biosimilars/News | Posted 03/09/2021

German-headquartered companies Formycon and Bioeq have announced a European marketing authorization application for their ranibizumab biosimilar, FYB201.

Human insulin ‘similar biologic’ InsuTrend launched in India

Biosimilars/News | Posted 27/08/2021

India-based company Anthem Biosciences (AnthemBio) announced that it has launched its human insulin ‘similar biologic’ InsuTrend in India.

EMA recommends approval of Samsung Bioepis/Biogen’s ranibizumab biosimilar Byooviz

Biosimilars/News | Posted 16/07/2021

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has given a positive opinion for the ranibizumab biosimilar Byooviz (SB11), produced by Samsung Bioepis and commercialized by Biogen.

Canada approves rituximab biosimilar Riabni

Biosimilars/News | Posted 09/07/2021

Canada’s drug regulator, Health Canada, has approved the rituximab biosimilar Riabni for the treatment of rheumatoid arthritis as well as chronic lymphocytic leukaemia and non-Hodgkin’s lymphoma.

Canada approves pegfilgrastim biosimilar Nyvepria

Biosimilars/News | Posted 02/07/2021

Canada’s drug regulator, Health Canada, has approved the filgrastim biosimilar Nyvepria (PF-06881894). The drug can be used to treat neutropenia (a lack of white blood cells) in cancer patients.

FDA accepts application for Lupin’s pegfilgrastim biosimilar

Biosimilars/News | Posted 21/06/2021

India-based generics manufacturer Lupin Pharmaceuticals (Lupin) announced on 2 June 2021 that the US Food and Drug Administration (FDA) had accepted the application for approval for its proposed pegfilgrastim biosimilar.

Trastuzumab emtansine ‘similar biologic’ Ujvira launched in India

Biosimilars/News | Posted 11/06/2021

India-based generics manufacturer Zydus Cadila (Zydus) announced on 24 May 2021 the launch of its trastuzumab emtansine ‘similar biologic’ Ujvira in India. The launch, according to Zydus ‘marks the world’s first biosimilar antibody drug conjugate (ADC) of trastuzumab emtansine’.

Clinical trials for aflibercept biosimilars

Biosimilars/News | Posted 04/06/2021

Sandoz, the generics division of Novartis, has announced the start of a phase III clinical trial of its aflibercept (Eylea) biosimilar, a treatment for age-related macular degeneration. Clinical trials for a number of competitive biosimilars are also underway.

Argentina approves bevacizumab similar biological medicine Zutrab

Biosimilars/News | Posted 26/03/2021

The Argentina-based Richmond Laboratory (Laboratorios Richmond) announced on 19 March 2021 that it had gained approval from Argentina’s National Administration of Drugs, Foods and Medical Devices (Administración Nacional de Medicamentos, Alimentos y Tecnología Médica, ANMAT) for its similar biological medicine (medicamento biológico similar) Zutrab (bevacizumab).

FDA approves first interchangeable insulin glargine biosimilar

Biosimilars/News | Posted 30/07/2021

In a landmark decision, the US Food and Drug Administration (FDA) has approved its first interchangeable biosimilar.

China approves sintilimab plus bevacizumab copy biological Byvasda

Biosimilars/News | Posted 23/07/2021

China-based drugmaker Innovent Biologics (Innovent) announced on 29 June 2021 that China’s National Medical Products Administration (NMPA), formerly the China Food and Drug Administration (CFDA), has approved the combination drug Tyvyt (sintilimab) plus bevacizumab copy biological Byvasda (IBI-305).

Canada approves five adalimumab biosimilars in last six months

Biosimilars/News | Posted 31/05/2021

Since October 2020, Canada’s drug regulator, Health Canada, has approved no less than five adalimumab biosimilars for the treatment of multiple chronic inflammatory diseases.

Australia approves adalimumab biosimilar Abrilada

Biosimilars/News | Posted 21/05/2021

Australia’s regulatory agency, the Therapeutic Goods Agency (TGA), has approved the adalimumab biosimilar Abrilada (PF-06410293).

EC approves bevacizumab biosimilar Abevmy

Biosimilars/News | Posted 14/05/2021

On 26 April 2021, India-based biologicals specialist Biocon Biologics (Biocon) announced that its bevacizumab biosimilar, Abevmy (MYL 1402O), which it co-developed with US-based drugmaker Viatris (formerly Mylan), had received European Commission (EC) approval.

Samsung Bioepis launches Hadlima in Australia and Canada

Biosimilars/News | Posted 07/05/2021

Korea-based Samsung Bioepis (Samsung and Biogen’s joint venture) announced on 29 March 2021 that it had now launched its adalimumab biosimilar, Hadlima (SB5), in Australia and Canada.

LG Chem gains approval for adalimumab biosimilar in Japan

Biosimilars/News | Posted 30/04/2021

Japan-based LG Chem (formerly LG Life Sciences) announced on 23 March 2021 in a public filing that it had received approval from Japan’s medicines regulatory agency, the Pharmaceuticals and Medical Devices Agency (PMDA), for 20 mg, 40 mg and 80 mg syringe, and 40 mg pen formulations of its adalimumab biosimilar, Adalimumab BS MA (LBAL).

EC approval for bevacizumab biosimilar Alymsys/Oyavas

Biosimilars/News | Posted 23/04/2021

The European Commission (EC) granted marketing authorization for the bevacizumab biosimilar Alymsys/Oyavas (MB02), on 31 March 2021. The biosimilar is developed by mAbxience, a biopharmaceutical firm with offices in Spain, Argentina and Switzerland.

Advances for Formycon and Alteogen’s eye disease biosimilar candidates

Biosimilars/News | Posted 16/04/2021

In March 2021, Formycon confirmed the resubmission strategy for their Lucentis® (ranibizumab) biosimilar candidate (FYB2010) in the US. In addition, Alteogen announced the completion of its phase I clinical trial of Eylea® (aflibercept) biosimilar (ALT-L9). Both of these biological drugs are used to treat conditions leading to the loss of vision.

FDA accepts application for adalimumab biosimilar CHS-1420

Biosimilars/News | Posted 09/04/2021

US-based Coherus BioSciences (Coherus) announced on 17 February 2021 that the US Food and Drug Administration (FDA) had accepted the application for their proposed adalimumab biosimilar CHS-1420.

EC approves adalimumab biosimilar Yuflyma

Biosimilars/News | Posted 19/03/2021

On 15 February 2021, South Korea-based biotechnology company Celltrion Healthcare (Celltrion) announced that its adalimumab biosimilar, Yuflyma (CT P17), had received European Commission (EC) approval.

EMA recommends approval of four bevacizumab biosimilars

Biosimilars/News | Posted 12/03/2021

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 29 January 2021 that it had recommended granting marketing authorization for the bevacizumab biosimilars Alymsys and Oyavas. Then on 26 February 2021, the agency announced that it had recommended approval of the bevacizumab biosimilars Abevmy and Lextemy.

China accepts IND application for daratumumab copy biological HLX15

Biosimilars/News | Posted 12/03/2021

China-based drugmaker Shanghai Henlius Biotech (Henlius) announced on 13 January 2021 that the investigational new drug (IND) application for its daratumumab copy biological, HLX15, had been accepted by China’s drug regulator, the National Medical Products Administration (NMPA), allowing it to carry out clinical trials in the country.

Latest launches for adalimumab biosimilars in Canada and Japan

Biosimilars/News | Posted 05/03/2021

There has been a lot of news recently when it comes to adalimumab biosimilars. Sandoz, Fresenius Kabi, Fujifilm Kyowa Kirin Biologics/Mylan and Viatris have all announced launches of adalimumab biosimilars.

FDA accepts application for bevacizumab biosimilar BAT1706

Biosimilars/News | Posted 26/02/2021

China-based Bio-Thera Pharmaceuticals (Bio-Thera) announced on 28 January 2021 that the US Food and Drug Administration (FDA) had accepted the Biologics License Application (BLA) for its proposed bevacizumab biosimilar, BAT1706.

Canada approves infliximab biosimilar Remsima SC

Biosimilars/News | Posted 19/02/2021

Canada’s drug regulator, Health Canada, has approved the infliximab biosimilar Remsima SC for the treatment of autoimmune diseases.

Innovent starts phase II trial for ipilimumab copy biological

Biosimilars/News | Posted 19/02/2021

China-based Innovent Biologics (Innovent) announced on 11 December 2020 that the first patient had been successfully enrolled and dosed in the randomized, double-blind, phase II multicentre clinical trial (NCT04590599) evaluating its ipilimumab copy biological (IBI310) in combination with TYVYT (sintilimab) for the treatment of patients with second-line or above advanced cervical cancer.

EMA recommends approval of adalimumab biosimilar Yuflyma

Biosimilars/News | Posted 12/02/2021

China extends indications for adalimumab and bevacizumab copy biologicals

Biosimilars/News | Posted 05/02/2021

Chinese biopharmaceutical firm Innovent Biologics (Innovent) announced that China’s National Medical Products Administration (NMPA), formerly the China Food and Drug Administration (CFDA), has approved new indications for its adalimumab and bevacizumab copy biologicals.

Canada approves three teriparatide biosimilars in 2020

Biosimilars/News | Posted 05/02/2021

Canada’s drug regulator, Health Canada, has approved the enoxaparin sodium biosimilars Apo-teriparatide, Teva-teriparatide and Osnuvo.

FDA approves rituximab biosimilar Riabni

Biosimilars/News | Posted 29/01/2021

US-based biotech giant Amgen announced on 17 December 2020 that it had received approval from the US Food and Drug Administration (FDA) for its rituximab biosimilar Riabni (ABP 798).

EMA recommends approval of adalimumab and insulin aspart biosimilars

Biosimilars/News | Posted 22/01/2021

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 11 December 2020 that it had recommended granting marketing authorization for the adalimumab biosimilar Yuflyma and for the insulin aspart biosimilar Kixelle.

Canada approves heparin biosimilars Redesca and Redesca HP

Biosimilars/News | Posted 22/01/2021

Canadian pharmaceuticals firm Valeo Pharma (Valeo) announced on 9 December 2020 that Canada’s drug regulator, Health Canada, had approved its low molecular weight heparin (LMWH) biosimilars Redesca and Redesca HP.

EC approval for pegfilgrastim biosimilar Nyvepria

Biosimilars/News | Posted 15/01/2021

The European Commission (EC) has granted marketing authorization for the pegfilgrastim biosimilar Nyvepria (PF-06881894), developed by US-based drugmaker Pfizer and its subsidiary Hospira.

China approves adalimumab copy biological HLX03

Biosimilars/News | Posted 08/01/2021

China-based drugmaker Shanghai Henlius Biotech (Henlius) announced on 7 December 2020 that China’s National Medical Products Administration (NMPA), formerly the China Food and Drug Administration (CFDA), had approved its adalimumab copy biological HLX03.

EMA and FDA accept application for adalimumab biosimilar AVT02

Biosimilars/News | Posted 08/01/2021

Iceland-based biopharmaceutical company Alvotech announced on 19 November 2020 that its US subsidiary, Alvotech USA, had filed an application for its adalimumab biosimilar (AVT02). The company also announced that the European Medicines Agency (EMA) had accepted for review its application for AVT02 with an EMA decision anticipated in the fourth quarter of 2021.

Trials of ustekinumab biosimilars advance

Biosimilars/News | Posted 29/05/2020

Japan-based Meiji Seika Pharma, together with the South Korean company Dong-A, have begun a phase I trial for their ustekinumab biosimilar. Meanwhile, the Australian firm NeuClone has reported results from the phase I trial of its ustekinumab biosimilar, NeuLara.

EMA recommends approval of bevacizumab biosimilar Onbevzi

Biosimilars/News | Posted 11/12/2020

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 13 November 2020 that it had recommended granting marketing authorization for the bevacizumab biosimilar Onbevzi.

EMA accepts application for bevacizumab biosimilar BAT1706

Biosimilars/News | Posted 04/12/2020

China-based Bio-Thera Pharmaceuticals (Bio-Thera) announced on 25 November 2020 that it had submitted an application for its proposed bevacizumab biosimilar, BAT1706, to the European Medicines Agency (EMA).

Australia approves etanercept and insulin aspart biosimilars

Biosimilars/News | Posted 04/12/2020

Australia’s drug regulator, the Therapeutic Goods Administration (TGA), announced in October 2020 the approval of etanercept and insulin aspart biosimilars.

FDA accepts application for ranibizumab biosimilar

Biosimilars/News | Posted 27/11/2020

Korea-based Samsung Bioepis (Samsung and Biogen’s joint venture) and partner US biotechnology company Biogen announced on 18 November 2020 that the US Food and Drug Administration (FDA) had accepted the application for their proposed ranibizumab biosimilar (SB11).

Canada approves enoxaparin biosimilars Inclunox and Noromby

Biosimilars/News | Posted 20/11/2020

Canada’s drug regulator, Health Canada, has approved the enoxaparin sodium biosimilars Inclunox and Noromby.

Innovent and Eli Lilly receive approval for rituximab copy biological in China

Biosimilars/News | Posted 06/11/2020

Innovent Biologics and Eli Lilly have received joint marketing approval from the National Medical Products Administration (NMPA) in China for their rituximab copy biological, Halpryza.

Canada approves trastuzumab biosimilar Kanjinti

Biosimilars/News | Posted 30/10/2020

Canada’s medicines regulator, Health Canada, has approved the trastuzumab biosimilar Kanjinti by Amgen. This marks the second trastuzumab biosimilar to be approved by Health Canada.

EMA accepts application for ranibizumab biosimilar from Samsung Bioepis

Biosimilars/News | Posted 23/10/2020

Korea-based Samsung Bioepis (Samsung and Biogen’s joint venture) announced on 6 October 2020 that the European Medicines Agency (EMA) has accepted to review its marketing authorization application for SB11, a biosimilar of Lucentis® (ranibizumab). If successful, this will be the first Lucentis® biosimilar available in Europe.

China accepts application for bevacizumab copy biological

Biosimilars/News | Posted 16/10/2020

The National Medical Products Administration (NMPA) in China has accepted an investigational new drug (IND) application for a bevacizumab copy biological developed by 3SBio and Samsung Bioepis.

EC approval for bevacizumab biosimilar Equidacent

Biosimilars/News | Posted 16/10/2020

Centus Biotherapeutics Ltd announced on 29 September 2020 that the European Commission (EC) granted marketing authorization for Equidacent, its Avastin (bevacizumab) biosimilar.