Biocon Biologics Scores EU Nod for Denosumab Biosimilars Vevzuo & Evfraxy

Biocon Biologics Ltd has secured a major regulatory win with the European Commission granting marketing authorisation for its denosumab biosimilars—Vevzuo and Evfraxy—marking a significant milestone in the company’s global expansion strategy. The approval follows positive recommendations from the Committee for Medicinal Products for Human Use (CHMP) and positions Biocon as a key player in Europe’s bone health therapeutics market.

 

Vevzuo, a biosimilar to Xgeva, is approved for the prevention of skeletal-related events in adults with advanced cancers involving bone and for treating giant cell tumour of bone in adults and skeletally mature adolescents. Evfraxy, a biosimilar to Prolia, is authorised for postmenopausal osteoporosis, bone loss due to hormone ablation in men, and glucocorticoid-induced bone loss.

 

Key Highlights:

 

Dual Approval: Vevzuo and Evfraxy authorised for distinct bone health indications across oncology and osteoporosis.

 

Scientific Validation: Approval based on robust Phase 3 trials demonstrating equivalence in efficacy, safety, pharmacokinetics, and immunogenicity.

 

Manufacturing Strength: Products developed by Biosimilar Collaborations Ireland Ltd, a Biocon Biologics subsidiary.

 

Market Impact: Opens access to a multi-billion-euro market, with Biocon now offering biosimilars for two of the most prescribed bone disease treatments in the EU.

 

Strategic Expansion: Reinforces Biocon’s footprint in regulated markets, following successful launches in the US, Canada, and Australia.

 

This dual green light from Europe not only boosts Biocon’s biosimilar portfolio but also underscores its commitment to affordable biologics for chronic conditions.

 

Sources: European Medicines Agency, Biocon Biologics, The Hindu BusinessLine