At its May 2025 meeting, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted positive opinions for three denosumab biosimilars: Sandoz’s Rolcya®, biosimilar to Amgen’s Prolia®, and Fresenius Kabi’s Conexxence® and Bomyntra®, biosimilars to Amgen’s Prolia® and Xgeva® respectively.
Rolcya® is a second Prolia® biosimilar for Sandoz, which was the first sponsor to obtain approval of denosumab biosimilars in Europe in May 2024 with Wyost® and Jubbonti®. Sandoz has previously reported that it expects to launch Wyost® and Jubbonti® in Europe from November 2025.
Fresenius Kabi entered a global settlement with Amgen in respect of its denosumab biosimilars in March 2025. The settlement resulted in the dismissal of all claims and counterclaims in US BPCIA litigation commenced by Amgen against Fresenius in October 2024. The global settlement permits European launch of Fresenius’ biosimilars “later in H2 of 2025” and launch in the US in “mid-2025”.
In addition to Sandoz’s Wyost® and Jubbonti®, there have been two other sponsors with denosumab biosimilars approved in Europe to date: Celltrion’s Stoboclo®/Osenvelt® (February 2025) and Samsung Bioepis’ Obodence™ and Xbryk™ (February 2025). CHMP positive opinions were adopted in March 2025 for Accord Healtcare’s Jubereq®/Osvyrti® and in April 2025 for Gedeon Richter’s Junod®/Yaxwer® (April 2025), Biocon’s Vevzuo®/Denosumab BBL (brand name currently under approval), mAbxience’s Izamby®/Denbrayce® and Zentiva’s Zadenvi®/Enwylma®.