At its March 2025 meeting, the European Medicine Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted positive opinions for three new biosimilars.
Accord Healthcare’s Jubereq® and Osvyrti®, biosimilars to Amgen’s Xgeva® and Prolia® (denosumab) respectively, have received recommendations for the same indications as the reference products.
In addition, the CHMP has recommended Celltrion’s Qoyvolma®, biosimilar to J&J/Janssen’s Stelara® (ustekinumab) for the treatment of moderate to severe plaque psoriasis in adults who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies.
To date, there have been three sponsors with denosumab biosimilars approved in Europe: Celltrion’s Stoboclo®/Ozenvelt® (February 2025), Samsung Bioepis’ Obodence™ and Xbryk™ (February 2025), and Sandoz’s Wyost® and Jubbonti® (May 2024). The EMA has accepted MAAs for a number of other denosumab biosimilars including for STADA/Alvotech (AVT03, October 2024), Teva (TVB-009P, October 2024), Gedeon Richter (July 2024), Fresenius Kabi (FKS518, July 2024), and Shanghai Henlius/Organon (HLX14, May 2024).
There are a number of ustekinumab biosimilars being marketed in the EU, with three launched during 2024, STADA/Alvotech’s Uzpruvo® and Sandoz’s Pyzchiva® in July 2024, and Celltrion’s SteQeyma® in November 2024. Previously approved ustekinumab biosimilars in Europe include Biocon’s Yesintek® (February 2025), Formycon/Fresenius’ Otulfi®/FYB202 (September 2024), Samsung Bioepis’ Eksunbi™ (September 2024) and Amgen’s Wezenla™ (June 2024).