Biocon

Biocon Biologics Limited, a wholly-owned subsidiary of Biocon Limited (BSE code: 532523, NSE: BIOCON), today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending the granting of a marketing authorisation to its Pertuzumab biosimilar as 420 mg concentrate solution for infusion, under the brand name Pebrilzo®, for the treatment of HER2‑positive breast cancer across multiple disease stages. The positive opinion follows the review of the marketing authorization application submitted by Biocon Biologics Ireland Limited (formerly Biosimilar Collaborations Ireland Limited), an indirect wholly-owned subsidiary of Biocon Biologics Limited. Shreehas Tambe, CEO & Managing Director, Biocon, said: “The positive CHMP opinion for our Pertuzumab biosimilar marks an important step toward expanding access to biologic therapies for patients with HER2-positive breast cancer in Europe. As the first monoclonal antibody biosimilar to receive a positive CHMP opinion under EMA's tailored clinical development approach, it reflects an important milestone in the evolution of biosimilar science and greater regulatory confidence on advanced analytical and clinical pharmacology evidence to establish biosimilarity.” The European Commission will now proceed with the final review of the application and issue its decision. Following a positive decision, the Summary of Product Characteristics (SmPC) will be available in all official European Union languages, while the European Public Assessment Report (EPAR) will be published on the EMA website in the weeks following the decision. Until marketing authorisation is granted by the European Commission, the product is not authorised for use in the European Union.

Biocon

Biocon’s Pertuzumab Becomes First Biosimilar to Secure EMA CHMP Approval Recommendation Under New Tailored Clinical Approach