Biosimilars

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.