Biocon's Pertuzumab Biosimilar Secures EMA CHMP Approval Recommendation

Biocon Biologics Limited announced a significant achievement for its Pertuzumab biosimilar, Pebrilzo®. The biosimilar received a positive recommendation from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA). This marks the first monoclonal antibody biosimilar to gain such an opinion under the EMA's tailored clinical development approach.

The biosimilar is designed for HER2-positive breast cancer treatment across various stages. This recommendation comes after a thorough review of the marketing authorization application by Biocon Biologics Ireland Limited, an indirect subsidiary of Biocon Biologics Limited.

Biocon's CEO, Shreehas Tambe, emphasized the importance of expanding access to biologic therapies in Europe. The European Commission will conduct a final review, potentially leading to a formal marketing authorisation.