Biocon's pertuzumab biosimilar receives positive EU CHMP opinion for HER2-positive breast cancer

Biocon Biologics’ pertuzumab biosimilar, branded Pebrilzo, has become the first monoclonal-antibody biosimilar to receive a positive opinion under the EMA’s new tailored clinical development pathway. The CHMP recommended marketing authorisation for a 420 mg concentrate intended for HER2-positive breast cancer, both in neoadjuvant and adjuvant settings. Biocon’s data, including structural, functional and pharmacokinetic comparisons, demonstrated high similarity to the reference biologic with no clinically relevant differences in safety or efficacy.

The recommendation now proceeds to the European Commission, which will decide on final approval and publish the product’s official documentation. CEO Shreehas Tambe highlighted the step as a move toward broader access to biologic therapies for European patients.