Biocon Biologics Wins EMA CHMP Backing for Pertuzumab Biosimilar Pebrilzo

Biocon Biologics Ltd., a wholly owned subsidiary of Biocon Ltd. (BIOCON.NS), said the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion on Sept. 23, 2026, recommending marketing authorization for its pertuzumab biosimilar, Pebrilzo, a copy of Roche's breast cancer drug Perjeta. A positive CHMP opinion is typically followed by European Commission approval within roughly two months. The recommendation moves Biocon's biosimilar closer to the European market, where pertuzumab is used to treat HER2-positive breast cancer. Biocon did not disclose projected pricing or launch timing. The company continues to expand its biosimilar portfolio in regulated markets.