Biosimilars/News
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, received regulatory approvals in the US, Europe, Canada, and the UK, expanding treatment options for Crohn’s disease, psoriasis related conditions, and ulcerative colitis.
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.
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).
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.
Canada approves pegfilgrastim biosimilar Armlupeg
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
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.
EC approval for three ustekinumab biosimilar: Eksunbi, Fymskina, Otulfi
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
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.
FDA approves second strength of trastuzumab biosimilar Hercessi
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.
