Biocon Biologics locks in launch timelines for denosumab biosimilars across Europe and global markets

Biocon Biologics announced that it can begin commercialising its denosumab biosimilars Vevzuo and Evfraxy in Europe from December 2, 2025, leveraging EU-wide marketing authorisation granted earlier this year. These products target osteoporosis and cancer‑related bone diseases, offering more affordable alternatives to Amgen’s reference drugs Prolia and Xgeva. The company has already secured UK market access through MHRA approvals, giving it coverage across major European bone‑health markets.​

Today’s disclosure also aligns with Biocon’s global strategy, under which it previously reached a settlement with Amgen to launch Bosaya and Aukelso—its denosumab biosimilars—in the U.S. from October 1, 2025. With regulatory clearances spanning the U.S., EU, UK and planned “rest of world” territories, Biocon Biologics positions itself as a key player in the fast‑growing denosumab biosimilar space, aiming to expand patient access while tapping a multibillion‑dollar global market.​

Key Highlights

Biocon Biologics secures commercial launch date for denosumab biosimilars in Europe starting December 2, 2025.​

Products: Vevzuo and Evfraxy for osteoporosis and oncology‑related bone loss.​

EU marketing authorisation and UK MHRA approvals enable broad European rollout.​

Separate settlement allows U.S. launch of Bosaya and Aukelso from October 1, 2025.​

Denosumab biosimilars address large, growing markets in bone health, improving affordability and access.​

Sources: Biocon and Biocon Biologics regulatory filings and press releases; Business Standard, ScanX, SV Healthcare, Pearce IP, Center for Biosimilars.​