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:
- Shanghai Henlius’ Bildyos® and Bilprevda®, biosimilars to Amgen’s Xgeva® and Prolia® (denosumab), were recommended for all indications of the reference products. Henlius’ marketing authorisation application for the biosimilars (HLX14) had been accepted by the EMA in May 2024. In June 2022, Henlius entered into a licence agreement with Organon regarding HLX14 under which Organon has exclusive global commercialisation rights for all countries except China, Hong Kong, Macau and Taiwan. Henlius and Organon were sued by Amgen in the US in relation to their denosumab biosimilars in June 2025.
- Alteogen’s Eyluxvi® (ALT-L9), biosimilar to Regeneron/Bayer’s Eylea® (aflibercept, 2mg), received a positive CHMP opinion for the treatment of nAMD, macular oedema secondary to retinal vein occlusion, diabetic macular oedema and myopic choroidal neovascularisation. Alteogen submitted its MAA in July 2024.
- Biocon’s Usrenty®, biosimilar to J&J/Janssen’s Stelara® (ustekinumab), was recommended for treatment of moderate to severe plaque psoriasis in adults and children from the age of 6, active psoriatic arthritis in adults and moderately to severely active Crohn’s disease in adults. Biocon received European Commission approval for another ustekinumab biosimilar Yesintek® (Bmab 1200) in February 2025 for the same indications. In August 2024, Biocon announced that it had signed a patent settlement and licence agreement with Janssen which enables commercialisation of its ustekinumab biosimilar in Europe, the United Kingdom, Canada and Japan (launch date unknown).
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).