Biocon Limited has informed the Exchange regarding a press release dated July 07, 2025, titled "Biocon Biologics Receives MHRA UK Approval for Vevzuo® and Evfraxy®, Denosumab Biosimilars".
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Biocon Biologics, a subsidiary of Biocon Ltd, has received marketing authorisation from the UK medicines regulator MHRA for two Denosumab biosimilars: Vevzuo® (for bone-related complications in advanced cancer and giant cell tumour of bone) and Evfraxy® (for osteoporosis in postmenopausal women and men, and bone loss conditions). Clinical trials showed both biosimilars have comparable safety and efficacy to the reference product. The company had also recently secured European Commission approval for the same biosimilars, enabling commercialisation across the EU and EEA. This expands Biocon Biologics' commercial footprint in two major regulated markets.
Positive for shareholders — UK and EU approvals open up additional revenue streams from the Denosumab biosimilar portfolio, strengthening Biocon Biologics' global biosimilars business and supporting long-term growth, though immediate stock impact may be modest as financial contribution will depend on launch timelines and market share.