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Positive CHMP Opinions for Henlius’ Denosumab, Alteogen’s Aflibercept and Biocon’s Ustekinumab

Jul 25, 2025

On 25 July 2025, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) published the outcomes of its July meeting, with positive opinions for the following denosumab, aflibercept and ustekinumab biosimilars:

There are currently 6 sponsors with denosumab biosimilars approved in Europe, although none have yet been launched:  Sandoz’s Wyost® and Jubbonti® (May 2024), Celltrion’s Stoboclo® and Osenvelt® (February 2025), Samsung Bioepis’ Obodence™ and Xbryk™ (February 2025), Gedeon Richter’s Junod® and Yaxwer®, mAbxience’s Izamby® and Denbrayce® and Biocon’s Evfraxy® and Vevzuo® (each in early July 2025), and Fresenius’ Conexxence® and Bomyntra® (late July 2025).  Accord Healthcare’s Jubereq® and Osvyrti® received CHMP positive opinions in March 2025 and the EMA has accepted denosumab biosimilar MAAs including for Teva (TVB-009P, October 2024) and STADA/Alvotech (AVT03, October 2024).

There are 7 aflibercept (2mg) biosimilars approved in Europe and not yet launched: Biocon’s Yesafili® (September 2023), Sandoz’s Afqlir® (November 2024), Samsung Bioepis/Biogen’s Opuviz™ (SB15) (November 2024), Formycon/Klinge’s Baiama® and Ahzantive® (January 2025), Celltrion’s Eydenzelt® (February 2025), and Amgen’s Pavblu® (April 2025).

There are a number of ustekinumab biosimilars now marketed in the EU, with STADA/Alvotech’s Uzpruvo® and Sandoz’s Pyzchiva® launched in July 2024 and Celltrion’s Steqeyma® launched in November 2024.  Approved ustekinumab biosimilars in Europe include Amgen’s Wezenla™ (June 2024), Samsung Bioepis’ Eksunbi™ (September 2024), Fresenius’ Otulfi®/FYB202 and Formycon’s Fymskina® (September 2024), Accord’s Imuldosa® and Absimky® (December 2024) and Biocon’s Yesintek® (February 2025).