Biosimilars

EC approves eight biosimilars, six more await final authorization

Biosimilars/News | Posted 22/04/2025

The European Commission (EC) granted marketing authorization for eight biosimilars: Biocon’s Yesintek,Celltrion’s Avtozma, Eydenzelt, Osenvelt and Stoboclo; Samsung Bioepis’ Obodence and Xbryk, and CuraTeQ Biologics’ Zefylti in February 2025.

EMA recommends approval for three biosimilars: Jubereq, Osvyrti, and Qoyvolma

Biosimilars/News | Posted 11/04/2025

On 27 March 2025, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted positive opinions, recommending the granting of a marketing authorization for three biosimilar medicines: Accord’s Jubereq and Osvyrti (denosumab), and Celltrion’s Qoyvolma (ustekinumab).

How the WHO is expanding access to biosimilars

Biosimilars/Research | Posted 11/04/2025

The World Health Organization (WHO) has highlighted its role in expanding global access to biosimilars in a February 2025 feature article, ‘Biosimilars: expanding access to essential biologic therapies’ [1].

FDA biosimilar approvals in March 2025: Bomyntra, Conexxence, and Omlyclo

Biosimilars/News | Posted 07/04/2025

In March 2025, the US Food and Drug Administration (FDA) approved three biosimilars: Omlyclo (omalizumab-igec), the first and only biosimilar designated as interchangeable with Xolair, as well as Bomyntra and Conexxence (denosumab-bnht), which reference Xgeva and Prolia (denosumab)

Stelara biosimilars enter US market with 85% discount in 2025

Biosimilars/General | Posted 28/03/2025

In February 2025, Teva Pharmaceuticals and Alvotech announced the availability of Selardsi (ustekinumab-aekn) in the US, followed by Sandoz’s Pyzchiva (ustekinumab-ttwe). These two products are biosimilars to the originator drug, Johnson & Johnson’s Stelara (ustekinumab).

Canada approves pegfilgrastim biosimilar Pexegra

Biosimilars/News | Posted 21/03/2025

On 25 February 2025, Health Canada granted marketing authorization to India-based Kashiv BioSciences for its pegfilgrastim biosimilar, Pexegra, which references Amgen’s Neulasta (pegfilgrastim).

IFPMA publishes position on pharmacy-mediated substitution for biosimilars

Biosimilars/General | Posted 21/03/2025

In January 2025, the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) published a position paper, ‘Pharmacy-mediated substitution for biosimilars’.

Optimizing costs with biosimilars: Brazil's case

Biosimilars/Research | Posted 21/03/2025

The adoption of biosimilars, biological drugs similar to reference medications, has emerged as a pivotal strategy for reducing healthcare costs while maintaining efficacy and safety. A review by Azevedo, VF, et al.examines how Unimed Maringá, a private healthcare provider in Brazil, implemented a biosimilar management programme, achieving significant cost savings and broader patient access to essential therapies [1].

Insulin aspart and denosumab biosimilars approved in US

Biosimilars/News | Posted 12/03/2025

In February 2025, the US Food and Drug Administration (FDA) approved Sanofi-Aventis’ Merilog (insulin aspart-szjj), referencing NovoNordisk’s NovoLog (insulin aspart); and Samsung Bioepis’ Ospomyv and Xbryk (denosumab-dssb), referencing Amgen’s Prolia and Xgeva, respectively. Additionally, the FDA granted a provisional determination of interchangeability designation for both Ospomyv and Xbryk with its reference medicines.

The ustekinumab shift: biosimilars displace Stelara’s market leadership

Biosimilars/General | Posted 12/03/2025

The ustekinumab market is heating up as biosimilar developers aggressively challenge the dominance of Stelara, Johnson & Johnson’s blockbuster drug for autoimmune diseases. With eight biosimilars approved in Europe and seven in the US, the competition is fierce, and the stakes are high.

Biosimilars in low- and middle-income countries

Biosimilars/Research | Posted 05/03/2025

Biosimilars offer a viable route to treatment for those with non-communicable diseases (NCDs) living in low- and middle-income countries (LMICs). A review article published in GaBI Journal titled ‘Increasing adoption of quality-assured biosimilars to address access challenges in low- and middle-income countries,’ offers insights into the benefits of biosimilars for better access to biologics in LMICs, focusing on data from selected emerging markets (Brazil, Colombia, Malaysia, Mexico, Nigeria, Taiwan, and Turkey).

FDA approves tocilizumab biosimilar Avtozma

Biosimilars/News | Posted 05/03/2025

On 24 January 2025, the US Food and Drug Administration (FDA) has approved tocilizumab biosimilar, Avtozma (tocilizumab-anoh). Celltrion’s Avtozma (tocilizumab-anoh)/CT-P47 is a biosimilar referencing Roche/Genentech’s Actemra/RoActemra (tocilizumab).

Brazilian law establishes December 16 as National Biosimilar Day

Biosimilars/General | Posted 05/03/2025

On 6 January 2025, President Luiz Inácio Lula da Silva sanctioned Law 15.087/25, officially declaring December 16 as National Biosimilar Drug Day in Brazil. The law, published in the Official Gazette of the Union, aims to raise awareness about the importance of biosimilars in the healthcare system.

January 2025 biosimilar approvals in Europe

Biosimilars/News | Posted 25/02/2025

On 30 January 2025, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted positive opinions, recommending the granting of a marketing authorization for for three biosimilar medicines: Dyrupeg (pegfilgrastim), Pavblu (aflibercept) and its duplicate Skojoy (aflibercept).

EC approves eight biosimilars, eight more await final authorization

Biosimilars/News | Posted 18/02/2025

The European Commission (EC) granted marketing authorization for eight biosimilars: Sandoz’s Afqlir, Formycon’s Ahzantive/Baiama, Accord Healthcare’s Absimky and Imuldosa, Samsung Bioepis’ Opuviz, Midas Pharma’s Ranibizumab Midas, and Prestige Biopharma’s Tuznue during September 2024 to January 2025.

Canada approves first omalizumab biosimilar Omlyclo

Biosimilars/News | Posted 06/02/2025

On 6 December 2024, Health Canada approved Celltrion’s Omlyclo (CT-P39) omalizumab biosimilar – the first and only omalizumab biosimilar currently available in Canada. The product is a biosimilar of Novartis’ Xolair.

Positive safety and efficacy primary endpoint results for AVT05 (golimumab proposed biosimilar)

Biosimilars/Research | Posted 28/01/2025

In November 2024, at the American College of Rheumatology (ACR) Convergence 2024, Alvotech shared the positive results of the primary endpoint of their comparable safety and efficacy study for their golimumab proposed biosimilar, AVT05 [1]. This is a biosimilar candidate to Janssen Biotech’s anti-inflammatory drug product, Simponi.

EMA recommends approval for tocilizumab biosimilar Avtozma and filgrastim biosimilar Zefylti

Biosimilars/News | Posted 28/01/2025

On 12 December 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 for two more biosimilars: Celltrion’s Avtozma and CuraTeQ Biologics’ Zefylti.

Ustekinumab biosimilars Yesintek, SteQeyma, and Otulfi approved by FDA, EMA and Health Canada

Biosimilars/News | Posted 21/01/2025

In late 2024 and early 2025, multiple ustekinumab biosimilars, including Yesintek, SteQeyma, and Otulfi, which are biosimilars referencing Janssen/Johnson & Johnson’s (J&J) Stelara, received regulatory approvals in the US, Europe, Canada, and the UK, expanding treatment options for Crohn’s disease, psoriasis related conditions, and ulcerative colitis.

Are interchangeable biosimilars at risk?

Biosimilars/Research | Posted 21/01/2025

In the US, the interchangeability designation earned by some biosimilars, now allows them to be substituted at pharmacy level, without physician approval. This has bolstered patient and physician confidence in these products, boosting their uptake. However, study published in GaBI Journal now examines how misinformation about interchangeable biosimilars undermines US health policy, physician confidence, and patient health [1].

EMA recommends approval for four denosumab biosimilars: Obodence, Osenvelt, Stoboclo, Xbryk

Biosimilars/News | Posted 15/01/2025

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion recommending the granting of marketing authorization for four denosumab biosimilars: Obodence and Xbryk (SB16), developed by Samsung Bioepis, on 14 November 2024, and Stoboclo and Osenvelt (CT-P41), developed by Celltrion, on 12 December 2024. These biosimilars are based on Amgen’s reference products Prolia and Xgeva, respectively.

Comparative efficacy studies: where are we now?

Biosimilars/Research | Posted 08/01/2025

In an article published in GaBI Journal titled ‘Comparative efficacy studies of biosimilars: data versus theoretical risks, beliefs, and comfort’ [1], Professor Pekka Kurki, a Clinical Immunology Professor at University of Helsinki, Finland and a member of the Finnish Medicines Agency (Fimea), explores the current position on biosimilar efficacy studies held by medicines agencies across the globe.

EMA recommends approval of three aflibercept biosimilars: Ahzantive, Baiama, and Eydenzelt

Biosimilars/News | Posted 08/01/2025

On 14 November and 12 December 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 three aflibercept biosimilars: Baiama, its duplicate, Ahzantive, and Eydenzelt.

Canada approves first tocilizumab biosimilar Tyenne

Biosimilars/News | Posted 03/12/2024

On 11 October 2024, Health Canada approved Fresenius Kabi’s tocilizumab biosimilar, Tyenne – the first and only tocilizumab biosimilar currently available in Canada – which references Roche’s Actemra/RoActemra (tocilizumab).

Pertuzumab biosimilar HLX11 meets primary endpoint in phase III comparative clinical study

Biosimilars/Research | Posted 03/12/2024

Shanghai Henlius Biotech and Organon announced on 30 September 2024 that their phase III comparative clinical trial for HLX11, an investigational biosimilar to Perjeta (pertuzumab), met its primary endpoint.

Uzpruvo/AVT04 biosimilar in profile

Biosimilars/Research | Posted 26/11/2024

Alvotech and STADA’s Uzpruvo/AVT04 is an ustekinumab biosimilar with similar efficacy, tolerability, safety and physicochemical and biological characteristics to Stelara, the reference product, as has been summarized in a recent study published in Clinical Drug Investigation [1].

EMA recommends approval for ustekinumab biosimilar Absimky and Imuldosa

Biosimilars/News | Posted 26/11/2024

On 17 October 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 Accord’s Absimky and Imuldosa, both of which are ustekinumab biosimilars referencing Janssen/Johnson & Johnson’s Stelara.

Biologicals and biosimilars available for IBD in Canada

Biosimilars/General | Posted 26/11/2024

The GI Society (Canadian Society of Intestinal Research) recently published an updated list of originator biologicals and biosimilars used to treat inflammatory bowel disease (IBD), specifically Crohn’s disease (CD) and ulcerative colitis (UC), in Canada.

Biosimilar medicines on the Pharmaceutical Benefits Scheme in Australia

Biosimilars/General | Posted 20/11/2024

In recent years, biosimilar medicines have gained increased support and access in Australia through the Pharmaceutical Benefits Scheme (PBS), a government programme designed to subsidize essential medicines and make them affordable for all Australians. Biosimilars are versions of original biological medicines that are highly similar in terms of quality, safety, and efficacy but are generally more affordable.

Canada approves pegfilgrastim biosimilar Armlupeg

Biosimilars/News | Posted 20/11/2024

India-based Lupin Limited (Lupin) announced on 23 August 2024 that it received marketing approval from Health Canada for its biosimilar pegfilgrastim biosimilar, which will be marketed as Armlupeg.

FDA approves fifth ustekinumab biosimilar Imuldosa

Biosimilars/News | Posted 13/11/2024

On 10 October 2024, the US Food and Drug Administration (FDA) approved Accord’s Imuldosa (ustekinumab-srlf), making it the fifth ustekinumab biosimilar referencing Janssen/Johnson & Johnson’s Stelara.

SBR issues consensus on interchangeability of reference products and biosimilars

Biosimilars/General | Posted 13/11/2024

On 25 September 2024, the Brazilian Society of Rheumatology (Sociedade Brasileira de Reumatologia, SBR) shared its position and consensus on the interchangeability between reference products and biosimilars, a topic of great importance for clinical practice, especially in light of recent regulatory developments by Brazilian Health Regulatory Agency, ANVISA (Agência Nacional de Vigilância Sanitária, ANVISA) and other international authorities.

EC approval for three ustekinumab biosimilars: Eksunbi, Fymskina, Otulfi

Biosimilars/News | Posted 05/11/2024

The European Commission (EC) granted marketing authorization for three ustekinumab biosimilars: Samsung Bioepis’ Eksunbi on 12 September 2024; Formycon’s Fymskina, and Fresenius Kabi’s Otulfi on 25 September 2024.

FDA approves biosimilars: ustekinumab Otulfi and eculizumab Epysqli

Biosimilars/News | Posted 29/10/2024

The US Food and Drug Administration (FDA) granted approval for two biosimilars, Formycon’s FYB202/Otulfi (ustekinumab-aauz) and Samsung Bioepis’ Soliris biosimilar, Epysqli (eculizumab-aagh), on 27 September and 22 July 2024, respectively. FYB202/Otulfi, a biosimilar referencing Johnson & Johnson’s Stelara, while Epysqli is a biosimilar referencing Alexion’s Soliris.

EMA recommends approval of aflibercept biosimilars Afqlir and Opuviz

Biosimilars/News | Posted 23/10/2024

On 19 September 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 two aflibercept biosimilars: Sandoz’s Afqlir and Samsung Bioepis’s Opuviz. These products are biosimilars of the reference product Eylea, developed by Regeneron and Bayer.

FDA approves second strength of trastuzumab biosimilar Hercessi

Biosimilars/News | Posted 23/10/2024

On 18 September 2024, the US Food and Drug Administration (FDA) granted approval for a second strength for Accord’s Hercessi (trastuzumab-strf), a biosimilar referencing Roche’s Herceptin.

FDA approves aflibercept biosimilars Enzeevu and Pavblu

Biosimilars/News | Posted 15/10/2024

The US Food and Drug Administration (FDA) has approved two more aflibercept biosimilars in August 2024. FDA granted approval for Sandoz’s Enzeevu (aflibercept-abzv) and Amgen’s Pavblu (aflibercept-ayyh) on 12 and 23 August 2024, respectively, making them the fourth and fifth approvals for a biosimilar referencing Eylea.

Innovative direct purchase agreement sees adalimumab biosimilar prices slashed

Biosimilars/General | Posted 15/10/2024

On 1 October 2024, Blue Shield of California in the US announced that it will pay far less for an adalimumab biosimilar. The transparent net price paid by the health plan provider will be US$525 per monthly dose, compared to the market-reported net price of reference product Humira at US$2,100.

EC approvals of four biosimilars: Tofidence, Wezenla, Avzivi and SteQeyma

Biosimilars/News | Posted 08/10/2024

The European Commission (EC) granted marketing authorization for four biosimilars between June and August 2024. In August 2024, the EC approved Celltrion’s SteQeyma (ustekinumab), in July 2024, Bio-Thera’s Avzivi (bevacizumab), and in June 2024, Amgen’s Wezenla (ustekinumab) and Biogen/Bio-Thera’s Tofidence (tocilizumab).

Stelara biosimilar available at US$0 for Accredo patients

Biosimilars/General | Posted 08/10/2024

On 5 September 2024, Evernorth Health Services in the US announced that a biosimilar of Johnson and Johnson’s Stelara (ustekinumab) will be available for US$0 out of pocket for eligible patients of its specialty pharmacy, Accredo.

Canada approves trastuzumab Adheroza and ustekinumab Steqeyma biosimilars

Biosimilars/News | Posted 01/10/2024

In August 2024, Henlius Biotech's trastuzumab biosimilar, Adheroza, received marketing approval from Health Canada. In July 2024, Celltrion’s ustekinumab biosimilar, Steqeyma (CT-P43), also gained Health Canada approval.

Ten best-selling biosimilars in Brazil in 2023

Biosimilars/General | Posted 01/10/2024

Biosimilars experienced a notable increase in sales during 2023, according to a study published by the Brazilian Association of Generic and Biosimilar Drug Industries (PróGenéricos). The data reveal that about 892,000 units of biosimilars were sold, representing a 43% growth compared to 2022.

EMA recommends approval of ranibizumab, rituximab and trastuzumab biosimilars

Biosimilars/News | Posted 24/09/2024

On 25 July 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 three more monoclonal antibody biosimilars: ranibizumab, rituximab, and trastuzumab.

Long-term real-world safety experience of biosimilars confirms concept of biosimilarity

Biosimilars/Research | Posted 24/09/2024

A review by Sagi S, et al. highlighted that biological medicines are well established in clinical practice for the treatment of many serious and chronic conditions [1].

COFEPRIS approves bevacizumab Bhava and trastuzumab Mamitra biocomparables

Biosimilars/News | Posted 18/09/2024

In July 2024, the Mexican regulatory authority COFEPRIS (Federal Commission for the Protection Against Sanitary Risk, Comisión Federal para la Protección contra Riesgos Sanitarios), approved two biocomparables – bevacizumab Bhava and trastuzumab Mamitra – from India-based Zydus.

International biosimilars players expanding their presence in China

Biosimilars/General | Posted 18/09/2024

The market for copy biologicals in China has significantly grown over the past decade. By early 2022, over 60 pharmaceutical companies were involved in the development of copy biological products [1].

EMA recommends approval of four ustekinumab biosimilars: Eksunbi, Fymskina, Otulfi, Steqeyma

Biosimilars/News | Posted 10/09/2024

On 25 July and 27 June 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 four ustekinumab biosimilars.

Boehringer and GoodRx make Humira biosimilar available at 92% discount

Biosimilars/General | Posted 10/09/2024

On 18 July 2024, it was announced that Boehringer Ingelheim (Boehringer) and GoodRx, the leading prescription savings platform in the US, launched a patient affordability initiative. From now on, Boehringer's citrate-free adalimumab-adbm, a biosimilar to Humira (adalimumab), will be available at a 92% discount to the list price of the AbbVie originator drug, exclusively on GoodRx.

FDA approves filgrastim biosimilar Nypozi

Biosimilars/News | Posted 04/09/2024

In addition to the biosimilars approval of Pyzchiva (ustekinumab-ttwe), with a provisional determination for interchangeability designation [1], and Ahzantive (aflibercept-mrbb) [2] on 28 June 2024, the US Food and Drug Administration (FDA) also approved Tanvex BioPharma’s Nypozi (filgrastim-txid) biosimilar, which references Amgen’s Neupogen.

Budget impact analysis of Rixathon introduction in Chile for non-Hodgkin lymphoma

Biosimilars/Research | Posted 04/09/2024

Non-Hodgkin lymphoma (NHL) is a significant global health concern, with diffuse large B-cell lymphoma (DLBCL) and follicular lymphoma (FL) being the most prevalent subtypes. In Chile, treatment for DLBCL and FL is covered by the public healthcare system, primarily using rituximab-based therapies. The recent introduction of rituximab biosimilars, such as Rixathon, presents a potential for cost savings in the healthcare system.

FDA approves third aflibercept biosimilar Ahzantive

Biosimilars/News | Posted 13/08/2024

The US Food and Drug Administration (FDA) was busy in June 2024. On 28 June 2024, the FDA granted approval for Formycon’s Ahzantive (aflibercept-mrbb), making it the third approval for a biosimilar referencing Eylea.

Biosimilars in inflammatory bowel disease: are we ready for multiple switches

Biosimilars/Research | Posted 13/08/2024

A review by Teixeira FV et al. discusses whether scientific evidence is sufficient to support multiple switches between biologicals and biosimilars in patients with inflammatory bowel diseases (IBD) [1].

Richmond to launch similar biologicals bevacizumab Yriviak and adalimumab Armixa

Biosimilars/News | Posted 06/08/2024

On 22 July 2024, the Argentina-based Laboratorios Richmond announced the launch of Yriviak, a bevacizumab similar biological, in Argentina. In the coming months, Richmond plans to launch their adalimumab similar biological, Armixa.

China approves Simcare’s cetuximab beta Enlituo

Biosimilars/News | Posted 30/07/2024

On 25 June 2024, Simcere Zaiming, a subsidiary of Simcere Pharmaceutical Group based in Nanjing, China, announced that Enlituo, a cetuximab beta injection, had received marketing approval from the China National Medical Administration (NMPA). This new-generation anti-epidermal growth factor receptor (EGFR) antibody drug was developed in collaboration with Mabpharm Limited.

Humira's resilience in the face of biosimilar competition

Biosimilars/General | Posted 30/07/2024

AbbVie’s Humira (adalimumab) has retained more than 80% of patients in the last year (Q3/2023 to Q2/2024), despite the availability of nine lower-priced rival products available in the US. This raises questions among drug pricing experts and analysts about whether the market for prescription biosimilars can survive in its current form.

Topline results from clinical development programme for candidate biosimilar AVT05 golimumab

Biosimilars/Research | Posted 23/07/2024

In April and June 2024, Icelandic biosimilar company Alvotech announced promising results from two clinical studies (AVT05-GL-P01, NCT05632211; AVT05-GL-C01, NCT05842213) for AVT05, their candidate golimumab biosimilar. Alvotech is the first company to announce topline results of clinical trials using a proposed biosimilar to Simponi (Janssen Biotech).

FDA approves third ustekinumab biosimilar Pyzchiva

Biosimilars/News | Posted 16/07/2024

On 28 June 2024, the US Food and Drug Administration (FDA) approved a third ustekinumab biosimilar, Pyzchiva (ustekinumab-ttwe). This product has been developed by Samsung Bioepis and is commercialised by Sandoz. It is a biosimilar of reference product Johnson & Johnson’s (J&J) Stelera.

FDA approves first eculizumab biosimilar Bkemv for two rare diseases

Biosimilars/News | Posted 09/07/2024

On 28 May 2024, the US Food and Drug Administration (FDA) approved Amgen's Bkemv (eculizumab-aeeb), the first biosimilar to AstraZeneca's rare blood disorder treatment Soliris approved in the US.

Efficacy and safety of the proposed P043 (Zerafil) vs reference omalizumab in allergic asthma

Biosimilars/Research | Posted 09/07/2024

In June 2024, the results of a phase III clinical trial of P043/Zerafil (omalizumab), a proposed biosimilar of Novartis’ Xolair produced by CinnaGen in Iran, showed no significant difference in efficacy and safety parameters to the originator.

EC biosimilar approvals: Omlyclo, Jubbonti/Wyost, and Pyzchiva

Biosimilars/News | Posted 03/07/2024

The European Commission (EC) granted marketing authorization for four biosimilars. They are Celltrion’s Omlyclo (omalizumab), Sandoz’s denosumab biosimilars Jubbonti and Wyost, and Samsung Bioepis’ Pyzchiva (ustekinumab). Furthermore, the EC approves expanded indication for Samsung Bioepis' Epysqli (eculizumab) to include treatment of atypical haemolytic uremic syndrome (aHUS).

Tocilizumab and pembrolizumab biosimilar advances for Korean firms

Biosimilars/Research | Posted 03/07/2024

In June 2024, Celltrion announced promising results from their phase III study for CT-P47, a biosimilar candidate of RoActemra (tocilizumab), in patients with rheumatoid arthritis (RA). Additionally, the company has submitted an investigational new drug (IND) application to the US Food and Drug Administration (FDA) for the phase III clinical trial of CT-P51, its Keytruda (pembrolizumab) biosimilar. This announcement follows the news that in April 2024, rival Korean biologicals company Samsung Bioepis initiated a phase III clinical trial for SB27, their pembrolizumab biosimilar.

Boehringer Ingelheim to expand access to adalimumab biosimilar

Biosimilars/General | Posted 03/07/2024

On 13 May 2024, Boehringer Ingelheim (Boehringer) announced an agreement with Quallent Pharmaceuticals, a private label pharmaceutical distributor, to help expand patient access to citrate-free adalimumab-adbm, Boehringer’s biosimilar to AbbVie’s Humira (adalimumab) in the US.

EMA recommends approval of biosimilar bevacizumab Avzivi

Biosimilars/News | Posted 25/06/2024

On 30 May 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 Avzivi (bevacizumab), Bio-Thera Solutions’ (Bio-Thera) biosimilar of the reference product Avastin.

Challenges and progress in the registration of biosimilars in Latin America

Biosimilars/General | Posted 25/06/2024

Biosimilar medicines offer an effective and economical alternative to biotechnological medicines, with a rapidly expanding global market. However, Latin America still faces several significant challenges. The obstacles and advancements experienced in recent years are detailed below.

FDA approves first interchangeable aflibercept biosimilars to treat macular degeneration

Biosimilars/News | Posted 19/06/2024

On 20 May 2024, the US Food and Drug Administration (FDA) approved Biocon Biologic’s Yesafili (aflibercept-jbvf) and Samsung Bioepis and Biogen's Opuviz (aflibercept-yszy) as the first interchangeable biosimilars to Regeneron and Bayer's Eylea (aflibercept). The Samsung Bioepis product has also been launched in South Korea under brand name, Afilivu.

Canada's path to biosimilar adoption and healthcare accessibility: insights from British Columbia

Biosimilars/General | Posted 19/06/2024

Canada’s British Columbia transitioned to biosimilars in November 2019, achieving significant cost savings reinvested in BC PharmaCare. This initiative has improved drug coverage, expanding access to various medications and medical devices.

FDA approves ustekinumab, trastuzumab, and tocilizumab biosimilars

Biosimilars/News | Posted 19/06/2024

In April 2024, the US Food and Drugs Administration (FDA) approved Alvotech and Teva’s Selarsdi (ustekinumab-aekn), a biosimilar to Stelara and Shanghai Henlius Biotech’s Herceptin biosimilar, Hercessi (trastuzumab-strf). This comes after the March 2024 news of the approval of Fresenius Kabi’s Tyenne (tocilizumab-aazg), the first tocilizumab biosimilar with an intravenous and subcutaneous formulation.

Update of biosimilars approved by Health Canada in 2023

Biosimilars/News | Posted 12/06/2024

Since November 2023, Canada’s drug regulator, Health Canada, has approved no fewer than five biosimilars for the treatment of deep vein thrombosis (DVT), cancer, plaque psoriasis, psoriatic arthritis, Crohn’s disease, ulcerative colitis and several serious retinal diseases, such as wet age-related macular degeneration.

EMA recommends approval of biosimilar tocilizumab Tofidence and ustekinumab Wezenla

Biosimilars/News | Posted 05/06/2024

On 25 April 2024, the European Medicine Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted positive opinions for two biosimilar medicines: Tofidence (tocilizumab) and Wezenla (ustekinumab), recommending the granting of marketing authorization. This comes following news that Wezlana reached the market in Canada in early March 2024.

Disruption in the US adalimumab market

Biosimilars/General | Posted 05/06/2024

In April 2024, Evernorth Health Services in the US announced that a biosimilar of AbbVie’s Humira ( adalimumab) will be available for US$0 out of pocket for eligible patients of its specialty pharmacy, Accredo. This announcement follows the news that prescriptions for adalimumab biosimilars have spiked to 36% after leading pharmacy benefit manager CVS Caremark removed the branded reference product from its major national commercial formularies in January 2024.

Canada approves three more biosimilars in 2022

Biosimilars/News | Posted 28/05/2024

Since the last update in June 2022, Health Canada has approved three more biosimilars (Myxredlin, Rymti, Elonox) in 2022 [1].

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).

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.

Unveiling key clinical findings for denosumab biosimilar candidates

Biosimilars/Research | Posted 07/05/2024

In April 2024, Henlius Biotech and Organon announced that the phase III comparative clinical trial for their investigational denosumab biosimilar (HLX14) met the primary endpoints. This follows the news released earlier in the year, that Alvotech and Polpharma achieved positive topline results from their pharmacokinetic (PK) studies for their denosumab biosimilar candidate (AVT03). The originator product is Amgen’s Prolia/Xgeva.

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.

Addressing the persistent gap in Medicare access to Humira biosimilars

Biosimilars/General | Posted 16/04/2024

In an article by Dr Joshua Cohen, he discusses the challenges facing the adoption of biosimilars in the US, particularly focusing on Medicare beneficiaries' access to these lower-cost alternatives to brand-name biologicals like Humira.

Topline results for Polpharma Biologics’ vedolizumab biosimilar candidate

Biosimilars/Research | Posted 16/04/2024

In February 2024, Polpharma Biologics (Polpharma) unveiled topline results demonstrating the pharmacokinetic (PK) and pharmacodynamic (PD) comparability of PB016, their biosimilar candidate for vedolizumab, with its reference drug, Entyvio, by Takeda Pharmaceutical.

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.