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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.

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EC approves eight biosimilars, six more await final authorization

Biosimilars/News | Posted 22/04/2025

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. 

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EMA recommends approval for three biosimilars: Jubereq, Osvyrti, and Qoyvolma

Biosimilars/News | Posted 11/04/2025

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).

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FDA biosimilar approvals in March 2025: Bomyntra, Conexxence, and Omlyclo

Biosimilars/News | Posted 07/04/2025

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)

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Canada approves pegfilgrastim biosimilar Pexegra

Biosimilars/News | Posted 21/03/2025

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). 

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Insulin aspart and denosumab biosimilars approved in US

Biosimilars/News | Posted 12/03/2025

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.

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FDA approves tocilizumab biosimilar Avtozma

Biosimilars/News | Posted 05/03/2025

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). 

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January 2025 biosimilar approvals in Europe

Biosimilars/News | Posted 25/02/2025

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).

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EC approves eight biosimilars, eight more await final authorization

Biosimilars/News | Posted 18/02/2025

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.

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Canada approves first omalizumab biosimilar Omlyclo

Biosimilars/News | Posted 06/02/2025

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.