Biocon's Pertuzumab Biosimilar Gets EMA CHMP Positive Opinion

Biocon Biologics Limited announced that its Pertuzumab biosimilar, Pebrilzo®, has received a positive opinion from the EMA's CHMP for marketing authorisation. This marks the first biosimilar to achieve this under EMA's tailored clinical development approach. The recommendation is for the treatment of HER2-positive breast cancer across multiple stages. The European Commission will now conduct the final review. The product's analytical and clinical pharmacology data demonstrated high similarity to the reference biologic with no clinically meaningful differences in quality, safety, or efficacy.