Beocon Biologics Ltd (BBL), based in Bengaluru, the Biosimilar and Subsidiary Company of Biocon Ltd, announced that the Committee of Medicine for Human Use (CHMP) of the European Medicines Agency has issued positive opinions about its positive indications of denesimilars.
These recommendations were presented after a review of comprehensive data packages and the results of clinical studies that demonstrate comparability with the reference product in terms of pharmacokinetic, safety, efficacy and immunogenicity profiles.
After a review of the CHMP recommendations by the European Commission, the approved indications and use will be included in the summary of the product characteristics (SMPC), and the European Public Evaluation Reports (EPARS)
(With internal bloc entrances Rohan das)
Posted on April 26, 2025