Biocon share price rose 2 percent in the early trade on April 28 following the company's subsidiary received positive CHMP opinions for biosimilar denosumab.
At 09:32am, Biocon was quoting at Rs 319.05, up Rs 7.05, or 2.26 percent, on the BSE.
Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has issued positive opinions recommending the approval of Biocon Biologics denosumab biosimilars candidates for distinct therapeutic indications for bone health: Vevzuo and Denosumab BBL.
The positive opinions are based on applications submitted by Biosimilar Collaborations Ireland, an indirect wholly owned subsidiary of Biocon Biologics.
These recommendations follow a review of comprehensive data packages, including clinical studies results, which demonstrated comparability with the reference product in terms of pharmacokinetic, safety, efficacy and immunogenicity profiles.
The European Commission will review the CHMP opinions and, following its decision, detailed information on the approved indications and usage will be included into the Summary of Product Characteristics (SmPCs), and the European Public Assessment Reports (EPARs), available in all official European Union languages.
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On April 23, Biocon board approved the raising of funds up to Rs 4,500 crore via the issuance of equity shares, non-convertible debt instruments along with warrants, by way of qualified institutions placement(s), rights issue, preferential allotment, or private placement(s), in one or more tranches.
Earlier in this month, Biocon Biologicsreceived USFDA approval for Jobevne (bevacizumab-nwgd), a biosimilar Bevacizumab for intravenous use. Jobevne, a recombinant humanized monoclonal antibody used to treat several different types of cancer, is a biosimilar to the reference product Avastin (bevacizumab).
The share touched a 52-week high of Rs 404.60 and a 52-week low of Rs 270.00 on 21 January, 2025 and 04 June, 2024, respectively.
Currently, the stock is trading 21.14 percent below its 52-week high and 18.17 percent above its 52-week low.
The market capitalisation stands at Rs 38,305.14 crore.
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