Biosimilars/News
Canada approves pegfilgrastim biosimilar Pexegra
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).
Insulin aspart and denosumab biosimilars approved in US
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.
FDA approves tocilizumab biosimilar Avtozma
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).
January 2025 biosimilar approvals in Europe
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
The European Commission (EC) granted marketing authorization for seven 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
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.
EMA recommends approval for tocilizumab biosimilar Avtozma and filgrastim biosimilar Zefylti
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
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.
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.
