Biocon arm gets market authorisation in EU for two biosimilars of Denosumab

Biocon Ltd. on Thursday, July 3, said the European Commission granted its subsidiary Biocon Biologics marketing authorisation in the Euorpean Union for the two biosimilars of Denosumab — Vevzuo or Evfraxy,Vevzuo is authorised for the prevention of bone complications in adults with advanced cancer involving bone and the treatment of adults and skeletally mature adolescents with giant tumour of bone, the company said in an exchange filing.
Meanwhile, Evfraxy is authorised for the treatment of osteoporosis in men with prostate cancer as increased risk of fractures or treatment of one loss associated with long-term systemic glucocorticoid therapy in adults.
As per clinical data, both Denosumab biosimilars have comparable quality, safety and efficacy to the reference product, the company said.The marketing authorisation follows a positive opinion issued by European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) on April 25, 2025, Biocon added.

“In the past 18 months, we have successfully secured regulatory approvals for three biosimilars in Europe and two in the UK. These Denosumab biosimilars mark another significant milestone in our rapid expansion, and support for healthcare systems in the region,” Shreehas Tambe, CEO and managing director of Biocon Biologics, said.

Biocon shares were up 0.15% at ₹369.1 apiece at 9.30 am on Thursday, July 2. The stock has gained 9% in the past month.

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