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Biocon Biologics secures EU approval for Vevzuo and Evfraxy biosimilars
The marketing authorisation follows a positive opinion issued by the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) on 25 April 2025, Biocon added.
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 cell tumour (GCT) of bone. Meanwhile, Evfraxy is authorised for the treatment of osteoporosis in men with prostate cancer at increased risk of fractures or treatment of bone loss associated with long-term systemic glucocorticoid therapy in adults.
'The approval of Vevzuo and Evfraxy in Europe underscores our strong scientific expertise and commitment to expanding patient access to essential medicines, including new therapeutic areas such as bone health. In the past 18 months, we have 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 regional healthcare systems,' said Shreehas Tambe, CEO and managing director, BBL.
Clinical data demonstrated that both Denosumab biosimilars exhibit comparable quality, safety, and efficacy to the reference product, the company claimed.
Analysts said that the space is already crowded, and the opportunity for Biocon could be around $20 million. Nuvama Institutional Equities said that Sandoz, Samsung, and Celltrion have already received approval, with several other filers including Stada/Alvotech, Teva, Fresenius, and Shanghai Henlius and Organon awaiting entry. The European market is estimated at $1.5 billion. Assuming 75 per cent price erosion and a 5 per cent market share, the opportunity for Biocon could be $20 million, Nuvama said.
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