Biocon Biologics receives EMA Committee positive opinions for Biosimilar Denosumab for bone health
Bengaluru: Biocon Biologics Ltd, a fully integrated global biosimilars company and subsidiary of Biocon Ltd, has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has issued positive opinions recommending the approval of its denosumab biosimilars candidates for distinct therapeutic indications for bone health: Vevzuo and Denosumab BBL (brand name is currently under approval).
"The positive opinions are based on applications submitted by Biosimilar Collaborations Ireland Limited, an indirect wholly owned subsidiary of Biocon Biologics Ltd," the Company Spokesperson said in a statement.
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.
Until marketing authorisations are granted by the European Commission, these products are not approved for use in the European Union.
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Biocon Biologics is a global player in biosimilars and insulin production and has achieved many “firsts” in the industry including the first to receive approval of a trastuzumab in the United States, OGIVRI (Trastuzumab-dkst), as well as FULPHILA (Pegfilgrastim-jmdb) and the first U.S. approval of an interchangeable biosimilar for SEMGLEE (insulin glargine). Biocon Biologics has a comprehensive portfolio of in-market and in-development biosimilar products across multiple therapies, including seven approved biosimilars in the United States and six in Canada, with a development pipeline of 20 biosimilar assets, including insulins and monoclonal antibodies spanning multiple therapy areas.
