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