Biosimilars
Ustekinumab biosimilars Yesintek, Steqeyma, and Otulfi approved by FDA, EMA and Health Canada
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?
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
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?
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
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
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
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
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
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
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.
