Biocon shares jump over 2% after EU panel’s positive nod for denosumab biosimilars

Shares of Biocon Ltd rose 2.07% to ₹318.30 in early trade on April 28, 2025, after its subsidiary received a major boost from European regulators. The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency issued positive opinions recommending the approval of Biocon Biologics’ biosimilar denosumab products — Vevzuo and Denosumab BBL — for treating bone health conditions.

The positive recommendation is based on extensive clinical data demonstrating comparability with the original reference product in pharmacokinetics, efficacy, safety, and immunogenicity profiles. The applications were submitted by Biosimilar Collaborations Ireland, an indirect wholly owned subsidiary of Biocon Biologics.

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Following this, the European Commission will review the CHMP’s recommendations and, after its decision, detailed product information will be published in the Summary of Product Characteristics (SmPC) and the European Public Assessment Reports (EPARs).

Other Key Updates:

  • On April 23, Biocon’s board approved fundraising of up to ₹4,500 crore through qualified institutional placements (QIPs), preferential allotments, or private placements.

  • Earlier this month, Biocon Biologics secured USFDA approval for Jobevne (bevacizumab-nwgd), a biosimilar for intravenous use, further strengthening its biosimilars portfolio.

Stock Update:

At 9:43 AM IST, Biocon shares were trading at ₹318.30, up ₹6.45 or 2.07%, compared to the previous close of ₹311.85. The company’s market capitalization now stands at approximately ₹379 billion.