Biosimilars/News
Australia approves ustekinumab biosimilar Uteknix
Australia’s medicines regulatory agency, the Therapeutic Goods Administration (TGA), approved Alvotech/Cipla’s ustekinumab biosimilar, Uteknix, on 11 February 2025.
EC approves eight biosimilars, six more await final authorization
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
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).
FDA biosimilar approvals in March 2025: Bomyntra, Conexxence, and Omlyclo
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)
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 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
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.
