Biosimilars/News

Celltrion/Teva launch trastuzumab biosimilar Herzuma in US

Celltrion and Teva announced in March 2020 that they have launched their trastuzumab biosimilar Herzuma (trastuzumab-pkrb) in the US. Herzuma can be used to treat breast and gastric cancer and has recently been approved in Canada [1].

Celltrion launches infliximab biosimilar Remsima SC in Europe

In a successful time for Celltrion Healthcare (Celltrion), the company has launched their infliximab biosimilar Remsima in Germany and the UK.

Amgen starts phase III trial for aflibercept biosimilar

US-based biotech giant Amgen is initiating a phase III clinical trial for a biosimilar of Regeneron’s Eylea (aflibercept).

FDA accepts application for Mylan’s bevacizumab biosimilar

US-based drugmaker Mylan announced on 27 February 2020 that the US Food and Drug Administration (FDA) had accepted its application for its bevacizumab biosimilar (MYL 1402O).

Mylan launches anti-cancer biosimilar in the US

The US drug market receives a new oncology biosimilar as Mylan launches its trastuzumab biosimilar, Ogivri.

Mylan launches anti-cancer biosimilar in the US

Pfizer launching biosimilars in US and Japan but not in EU

In early 2020, pharma giant Pfizer announced that it was launching its rituximab biosimilar in Japan and that it would be launching three new biosimilars onto the US market.

Phase III trial started in China for eculizumab copy biological

Korea-based Samsung Bioepis (Samsung and Biogen’s joint venture) is starting a phase III clinical trial in China for a copy biological of Soliris (eculizumab), made by Alexion Pharmaceuticals (Alexion).

EMA approval for rituximab biosimilar Ruxience

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 31 January 2020 that it had recommended granting marketing authorization for the rituximab biosimilar Ruxience.

Rituximab biosimilar ABP 798 submitted to FDA

US-based biotech giant Amgen and its partner Allergan announced on 19 December 2019 that their rituximab biosimilar (ABP 798) had been successfully submitted to the US Food and Drug Administration (FDA) for review.

Teriparatide biosimilar Terossa approved in South Korea

South Korea-based Daewon Pharmaceutical has obtained regulatory approval to begin marketing and selling its teriparatide biosimilar in Korea.

Phase I trials started for aflibercept and ustekinumab biosimilars

Phase I trials have started for proposed biosimilars of aflibercept and ustekinumab.

South Korean biologicals company Alteogen has, according to clinicaltrials.gov, started a phase I trial for its candidate aflibercept biosimilar ALT-L9.

Bevacizumab and teriparatide biosimilars launched in Japan

Biosimilars for osteoporosis treatment teriparatide and for anticancer drug bevacizumab were launched in Japan in late 2019.

Samsung Bioepis and AffaMed to start trastuzumab trial in China

China’s National Medical Products Administration (NMPA), formerly the China Food and Drug Administration (CFDA) has granted approval for partners Samsung Bioepis and AffaMed Therapeutics (AffaMed) to start a phase III trial for their trastuzumab product, SB3.

FDA approval for Amgen’s infliximab biosimilar Avsola

US-based biotech giant Amgen announced on 6 December 2019 that it had received approval from the US Food and Drug Administration (FDA) for its infliximab biosimilar Avsola (ABP 710).

Bio-Thera gains Chinese approval for adalimumab copy biological and starts ustekinumab trial

China’s National Medical Products Administration (NMPA), formerly the China Food and Drug Administration (CFDA) has approved Qletli, an adalimumab copy biological. The NMPA has also approved the Investigational New Drug (IND) application from Bio-Thera Solutions (Bio-Thera) to initiate a phase I clinical study for the proposed ustekinumab copy biological BAT2206.

Australia approves five biosimilars since June 2019

Australia’s regulatory agency, the Therapeutic Goods Agency (TGA) has approved five biosimilars since June 2019. The biosimilars approved in the country since then include three pegfilgrastim biosimilars, a trastuzumab biosimilar and a bevacizumab biosimilar.

Phase III trials started for bevacizumab and natalizumab biosimilars

Phase III trials have started for proposed biosimilars of bevacizumab and natalizumab.

EC approval for subcutaneous infliximab biosimilar Remsima SC

South Korean biotechnology company Celltrion Healthcare (Celltrion) announced on 26 November 2019 that it had received European Commission (EC) approval for the subcutaneous (SC) formulation of its infliximab biosimilar (CT-P13) in patients with rheumatoid arthritis (RA).

Lupin to launch etanercept and pegfilgrastim biosimilars in the US

India-based generics maker Lupin, which is expecting European approval for its etanercept biosimilar in March 2020, has announced plans to launch the drug on the US market soon after, alongside a pegfilgrastim biosimilar.

FDA approves adalimumab biosimilar Abrilada

US-based pharma giant Pfizer announced on 18 November 2019 that it had received approval from the US Food and Drug Administration (FDA) for its adalimumab biosimilar (PF 06410293).

Qilu starts phase III trial for denosumab copy biological

Chinese pharmaceutical company, Qilu Pharmaceutical (Qilu) is carrying out a phase III clinical trial for a copy biological of Amgen’s Prolia/Xgeva (denosumab).

Adalimumab copy biological accepted for review in China

China’s National Medical Products Administration (NMPA), formerly the China Food and Drug Administration (CFDA), has accepted an application for the approval of adalimumab copy biological UBP1211.

Teriparatide biosimilar Terrosa launched in Europe

Hungary-based Gedeon Richter (Richter) announced on 20 August 2019 that it had launched its teriparatide biosimilar Terrosa in Europe immediately following the patent expiry of the reference product in August 2019.

FDA approves pegfilgrastim biosimilar Ziextenzo

Sandoz, the generics division of Novartis, announced on 5 November 2019 that it had received approval from the US Food and Drug Administration (FDA) for its pegfilgrastim biosimilar Ziextenzo (LA-EP2006).

Tanvex BioPharma’s filgrastim biosimilar comes under fire

Taiwan-based biosimilars developer Tanvex BioPharma (Tanvex) is having a rough time lately. In July 2019, Amgen filed an infringement lawsuit against the company regarding its filgrastim biosimilar, TX01. Then in September 2019, US Food and Drug Administration (FDA) rejected Tanvex’s application for approval of TX01.

Bevacizumab ‘similar biologic’ Versavo launched in India

India-based generics manufacturer Dr Reddy’s Laboratories (Dr Reddy’s) announced on 19 August 2019 that it had launched its bevacizumab ‘similar biologic’, Versavo (DRZ_BZ) in India.

EMA approval for Pegfilgrastim Mundipharma

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 18 October 2019 that it had recommended granting of a marketing authorization for the pegfilgrastim biosimilar Pegfilgrastim Mundipharma.

Russian approval for non-originator dornase alfa

Russian biotechnology company Generium and Swiss-based cell-line producer Selexis announced on 17 September 2019 that the Russian Ministry of Health had approved their dornase alfa non-originator biological drug, Tigerase. The drug is a non-originator biological of Roche’s Pulmozyme (dornase alfa).

FDA approves Pfenex’s follow-on teriparatide product

US-based biotech firm Pfenex announced on 7 October 2019 that it had received approval from the US Food and Drug Administration (FDA) for its follow-on teriparatide product (PF708).

Biocon/Mylan launch first insulin glargine biosimilar in Australia

India-based biologicals specialist Biocon and US-based partner Mylan announced on 3 October 2019 the launch of the first insulin glargine biosimilar in Australia available on the Pharmaceutical Benefits Scheme (PBS).

Three darbepoetin alfa biosimilars approved in Japan

Three pharmaceutical companies have announced approval of their anaemia treatments for sale on the Japanese market, while Mochida reveals it will sell the first teriparatide biosimilar in the country.

iBio and CC-Pharming collaborate for rituximab copy biological in China

Biotechnology company iBio, self-professed leader in the plant-made pharmaceutical field, announced on 27 August 2019 that it will expand its collaboration with China-based CC-Pharming for a rituximab copy biological in China.

Positive EMA-CHMP opinion for SC infliximab biosimilar

South Korean biotechnology company Celltrion announced on 22 September 2019 that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) had recommended for approval the company’s subcutaneous (SC) formulation of its infliximab biosimilar (CT-P13) in patients with rheumatoid arthritis (RA).

Samsung Bioepis to supply Brenzys to Brazil under production development partnership

On 10 September 2019, Samsung Bioepis announced that it had signed a productive development partnership (PDP) with Brazil’s Ministry of Health to supply Brenzys, a similar biotherapeutic product to rheumatoid arthritis treatment Enbrel (etanercept), to Brazil for the next 10 years.

Trastuzumab biosimilar Herzuma approved in Canada

South Korean biotechnology company Celltrion announced on 10 September 2019 that Health Canada had approved its trastuzumab biosimilar Herzuma.

China approves new formulation of etanercept copy biological Yisaipu

China’s National Medical Products Administration (NMPA), formerly the China Food and Drug Administration (CFDA), has approved Yisaipu, an etanercept copy biological as a pre-filled syringe.

Herzuma gains Japanese approval for three-week cycle method

South Korean biotechnology company Celltrion announced at the end of August 2019 that Japan's Ministry of Health, Labour and Welfare (MHLW) had approved a three-week cycle method for its trastuzumab biosimilar, Herzuma (CT P6), in the treatment of breast cancer.

Revance Therapeutics focus on its own Botox biosimilar as work with Mylan is stalled

As Revance gives Mylan more time to decide whether to develop their joint Botox biosimilar, the firm is continuing to focus on its own Botox biosimilar, DAXI. It aims to launch the product in 2020.

Mylan launches adalimumab biosimilar Hulio in Spain

US-based drugmaker Mylan announced on 9 July 2019 the launch of its adalimumab biosimilar, Hulio, in Spain; the company’s first biosimilar in the country.

Heparin biosimilar to be marketed in Canada

Canadian pharmaceuticals firm Valeo Pharma Inc has been given the rights to market a biosimilar version of low molecular weight heparin (LMWH), which is used to prevent blood clots in a range of conditions.

Trastuzumab biosimilar to be distributed by Mundipharma

Singapore-based Prestige BioPharma’s (Prestige) trastuzumab biosimilar Tuznue (HD201) will be distributed in selected European markets exclusively by UK-based Mundipharma International (Mundipharma) and its independent associated companies. Tuznue is a biosimilar of Roche’s Herceptin (trastuzumab) which is used to treat patients with human epidermal growth factor receptor 2 (HER2)-overexpressing breast cancer, HER2-overexpressing metastatic gastric cancer or gastroesophageal junction adenocarcinoma.

Mylan launches first trastuzumab biosimilar in Australia

Global generics firm Mylan NV (Mylan) and collaborating Indian pharmaceuticals giant Biocon Ltd (Biocon) have announced the launch of the first trastuzumab biosimilar in Australia. The drug can be used to treat breast and stomach cancers and will be marketed as Ogivri.

Samsung Bioepis starts phase III trial for eculizumab copy biological

Korea-based Samsung Bioepis (Samsung and Biogen’s joint venture) is carrying out a phase III clinical trial for a copy biological of Soliris (eculizumab), made by Alexion Pharmaceuticals (Alexion).

Korean firms to launch biosimilars in Japan despite trade tensions

Despite increasing trade tensions between Japan and Korea, two Korean firms have confirmed that they intend to move ahead with the launch of their darbepoetin alfa biosimilars in Japan in the second half of 2019.

FDA approves adalimumab biosimilar Hadlima

Korea-based biosimilars maker Samsung Bioepis (Samsung and Biogen’s joint venture) announced on 24 July 2019 that it had received approval from the US Food and Drug Administration (FDA) for its adalimumab biosimilar (SB5).

EMA accepts first application for Chinese-made biosimilar HLX02

China-based Shanghai Henlius Biotech (Henlius) announced on 21 June 2019 that the regulatory submission for its proposed trastuzumab biosimilar (HLX02) had been accepted by the European Medicines Agency (EMA).

Rituximab copy biological accepted for review in China

China’s National Medical Products Administration (NMPA), formerly the China Food and Drug Administration (CFDA), has accepted an application for approval of rituximab copy biological IBI301.

FDA approves rituximab biosimilar Ruxience

US-based pharma giant Pfizer announced on 23 July 2019 that it had received approval from the US Food and Drug Administration (FDA) for its rituximab biosimilar (PF 05280586).

Lannett starts phase I trial for insulin glargine biosimilar in South Africa

US generics maker Lannett Company (Lannett) announced on 5 June 2019 that it had started a phase I clinical trial of its candidate insulin glargine biosimilar.

EMA accepts application for bevacizumab biosimilar from Samsung Bioepis

Korea-based Samsung Bioepis (Samsung and Biogen’s joint venture) announced on 19 July 2019 that the application for approval for its proposed bevacizumab biosimilar SB8 has been accepted for review by the European Medicines Agency (EMA).

Sandoz to start phase III trial for denosumab biosimilar

Sandoz, the generics division of Novartis, is planning to start a phase III trial for its candidate denosumab biosimilar GP2411 in patients with post-menopausal osteoporosis in collaboration with Germany-based biosimilars maker Hexal.

FDA approves bevacizumab biosimilar Zirabev

US-based pharma giant Pfizer announced on 28 June 2019 that it had received approval from the US Food and Drug Administration (FDA) for its bevacizumab biosimilar Zirabev (PF-06439535).

FDA approves trastuzumab biosimilar Kanjinti

US-based pharma giant Amgen and Netherlands-based Allergan announced on 13 June 2019 that it had received approval from the US Food and Drug Administration (FDA) for its trastuzumab biosimilar Kanjinti (ABP 980).

Alteogen gains approval to start aflibercept biosimilar trial in Korea

South Korean biologicals company Alteogen announced on 22 May 2019 that it had gained approval from the Korean Ministry of Food and Drug Safety (MFDS) to initiate a clinical trial for its aflibercept biosimilar, ALT‑L9.

Trastuzumab biosimilar from Prestige accepted for review by EMA

Singapore-based Prestige BioPharma (Prestige) announced on 28 May 2019 that the regulatory submission for its proposed trastuzumab biosimilar Tuznue (HD201) had been accepted by the European Medicines Agency (EMA).

Brazilian approval for trastuzumab follow-on biological Herzuma (trastuzumab-pkrb)

South Korean biosimilars firm Celltrion announced on 23 May 2019 that the Brazilian Health Surveillance Agency (Agência Nacional de Vigilância Sanitária, ANVISA) had approved its trastuzumab follow-on biological, Herzuma (trastuzumab-pkrb).

Sandoz’s rosuvastatin approved under China’s new Quality Consistency Evaluation system

Sandoz, the generics division of Novartis, announced on 9 May 2019 that it had received regulatory approval from China's National Medical Products Administration (NMPA) for its generic rosuvastatin, under the recently introduced Quality Consistency Evaluation (QCE) system.

Brazilian approval for trastuzumab follow-on biological Ontruzant

Korea-based Samsung Bioepis (Samsung and Biogen’s joint venture) announced on 27 May 2019 that the Brazilian Health Surveillance Agency (Agência Nacional de Vigilância Sanitária, ANVISA) had approved its trastuzumab follow-on biological, Ontruzant.

Trastuzumab biosimilar Ogivri approved in Canada

India-based biologicals specialist Biocon and US-based partner Mylan announced on 22 May 2019 that Health Canada had approved Mylan’s trastuzumab biosimilar Ogivri.

NeuClone to start phase I trial for ustekinumab biosimilar

Australian biologicals company NeuClone announced on 15 May 2019 that it would start a phase I clinical trial of its ustekinumab biosimilar, NeuLara, in the second half of 2019.

Russian approval for non-originator eculizumab

Russian biotechnology company Generium and Swiss-based cell-line producer Selexis announced on 9 April 2019 that the Russian Ministry of Health had approved their eculizumab non-originator biological drug, Elizaria. The drug is a non-originator biological of Soliris (eculizumab), which is made by Alexion Pharmaceuticals.

Adalimumab biosimilar Idacio launched in Germany

Fresenius Kabi, one of the independently operated business segments of global healthcare group Fresenius, announced on 3 May 2019 that it had launched its adalimumab biosimilar Idacio in Germany.

EMA approval for pegfilgrastim biosimilar Grasustek

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 26 April 2019 that it had recommended the granting of a marketing authorization for the pegfilgrastim biosimilar Grasustek.

FDA approves etanercept biosimilar Eticovo

Korean biosimilars maker Samsung Bioepis (Samsung and Biogen’s joint venture) announced on 25 April 2019 that it had received approval from the US Food and Drug Administration (FDA) for its etanercept biosimilar.

Intas launches trastuzumab similar biologic in India at 65% discount

India-based generics maker Intas Pharmaceuticals (Intas) announced on 9 April 2019 the launch of its product Eleftha, a ‘similar biologic’ of trastuzumab, in India. The new product, claims the company, will bring down the cost of breast cancer treatment by nearly 65%.

Rituximab biosimilar Truxima approved in Canada

Teva Canada Innovation, a subsidiary of Teva Pharmaceutical Industries, announced on 10 April 2019 that Health Canada had approved its rituximab biosimilar Truxima. This marks the first rituximab biosimilar to be approved by the Canadian medicines’ regulator.

EC approval for adalimumab biosimilar Idacio

Fresenius Kabi, the generics unit of German healthcare giant Fresenius, announced on 3 April 2019 that it had received European Commission (EC) approval for its adalimumab biosimilar Idacio (MSB11455).

Sandoz resubmits pegfilgrastim biosimilar to FDA

Sandoz, the generics division of Novartis, announced on 3 April 2019 that the regulatory submission for its proposed pegfilgrastim biosimilar (LA-EP2006) had been accepted by the US Food and Drug Administration (FDA).

Japanese approval for Lupin’s etanercept biosimilar

Indian generics manufacturer Lupin Pharmaceuticals (Lupin) announced on 26 March 2019 that its joint venture YL Biologics and Lupin (through its Japanese subsidiary, Kyowa Pharmaceutical Industry) had received approval from Japan’s medicines regulatory agency, the Pharmaceuticals and Medical Devices Agency (PMDA), for its etanercept biosimilar YLB113 in Japan.

Bio-Thera advances bevacizumab and tocilizumab copy biologicals

China-based Bio‑Thera Solutions (Bio‑Thera) has made a licensing agreement for its bevacizumab copy biological and has started a phase III trial for its tocilizumab copy biological.

FDA approves trastuzumab biosimilar Trazimera

Pharma giant Pfizer announced on 11 March 2019 that the US Food and Drug Administration (FDA) had approved its biosimilar version of Roche’s Herceptin (trastuzumab).

China approves rituximab copy biological

China’s National Medical Products Administration (NMPA), formerly the China Food and Drug Administration (CFDA), announced on 22 February 2019 that it had approved Hanlikon, a rituximab copy biological.

UK’s NICE recommends pertuzumab with biosimilar trastuzumab

The UK’s National Institute for Health and Care Excellence (NICE) has recommended originator pertuzumab with intravenous biosimilar trastuzumab and chemotherapy for the treatment of breast cancer.

EC approval for bevacizumab biosimilar Zirabev

US-based drugmaker pharma giant Pfizer announced on 19 February 2019 that it had received European Commission (EC) approval for its bevacizumab biosimilar Zirabev (PF 06439535).

Monoclonal antibody copy biologicals accepted for review in China

China’s National Medical Products Administration (NMPA), formerly the China Food and Drug Administration (CFDA), has accepted applications for approval of two monoclonal antibody copy biologicals (IB 305 and HLX22).

EC approval for pegfilgrastim biosimilar Fulphila

In January 2019, the pegfilgrastim biosimilar, Fulphila, received European Commission (EC) approval.

Three FDA approvals for Glenmark as it enters US branded dermatology market

Glenmark Pharmaceuticals Inc has been granted approval by the US Food and Drug Administration (FDA) for its generic versions of Zytiga, DermOtic oil and Qudexy XR, and has announced its entry into the US branded dermatology segment.

PanGen gains Malaysian approval for epoetin alfa biosimilar

South Korea-based biotechnology company PanGen Biotech (PanGen) announced on 7 February 2019 that Malaysia’s National Pharmaceutical Regulatory Agency has granted sales approval for Erisa, an epoetin alfa biosimilar.

EMA approval for adalimumab biosimilars Idacio and Kromeya

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 31 January 2019 that it had recommended granting marketing authorization for the adalimumab biosimilars Idacio and Kromeya.

Australia’s PBAC recommends substitution of adalimumab biosimilars

Australia’s Pharmaceutical Benefits Advisory Committee (PBAC) has recommended that the adalimumab biosimilars Amgevita and Hadlima ‘should be treated as equivalent’ to the brand-name biological Humira on the Australian Pharmaceutical Benefits Scheme (PBS).