Biocon Limited has informed the Exchange regarding a press release dated July 03, 2025, titled "Advancing Bone Health: European Commission ApprovesBiocon Biologics Denosumab Biosimilars".
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Biocon's subsidiary Biocon Biologics has received marketing authorisation from the European Commission for two Denosumab biosimilars: Vevzuo® (for bone complications in advanced cancer and giant cell tumour of bone) and Evfraxy® (for osteoporosis in men and postmenopausal women, plus bone loss linked to hormone therapy and long-term steroid use). Clinical trials showed both products have comparable quality, safety, and efficacy to the original reference drug. The approval follows a positive opinion from the European Medicines Agency's CHMP committee in April 2025. The company highlighted that this is its third biosimilar approval in Europe and second in the UK in the past 18 months, marking entry into the bone health therapeutic area. Europe has an addressable market of 32 million people aged 50+ living with osteoporosis and 2.74 million new cancer cases annually (2022 data).
Positive for Biocon — the EU approval opens a large new market segment in bone health, diversifies the biosimilars portfolio, and supports future revenue growth from Biocon Biologics, which already serves 5.8 million patients across 120+ countries with 9 commercialised biosimilars.