Biocon Biologics Secures UK Nod for Denosumab Biosimilars Vevzuo & Evfraxy, Expands Bone Health Portfolio

Biocon Biologics Ltd, a subsidiary of Biocon Ltd, has received marketing authorization from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) for its Denosumab biosimilars—Vevzuo and Evfraxy. These approvals mark a significant milestone in Biocon’s expansion into bone health therapeutics, reinforcing its position as a global biosimilars leader.

 

Vevzuo is approved for preventing skeletal-related events in adults with advanced cancers involving bone and for treating giant cell tumors of bone. Evfraxy, meanwhile, is indicated for osteoporosis in postmenopausal women and men at high fracture risk, as well as bone loss due to hormone ablation therapy or long-term steroid use.

 

The approvals follow a positive opinion from the European Medicines Agency’s CHMP and come shortly after Biocon received European Commission clearance for the same molecules. CEO Shreehas Tambe emphasized that these back-to-back approvals underscore Biocon’s scientific strength and commitment to affordable biologics.

 

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Source: Biocon – Denosumab Biosimilars Approved in UK & EU | Business Standard – Biocon Biologics Gets EU Nod