Biocon's Pertuzumab wins historic EMA CHMP nod under new tailored clinical pathway

The CHMP has advised granting marketing authorisation for the drug as a 420 mg concentrate solution for infusion

Biocon Biologics Limited, a wholly owned subsidiary of Biocon Limited, has received a positive recommendation from the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) for its Pertuzumab biosimilar, Pebrilzo.

The CHMP has advised granting marketing authorisation for the drug as a 420 mg concentrate solution for infusion, which is designed to treat HER2-positive breast cancer across multiple stages of the disease.

Notably, Pebrilzo stands as the first monoclonal antibody biosimilar to secure a positive CHMP opinion under the EMA’s new, tailored clinical development pathway. The final decision regarding its approval across the European Union now rests with the European Commission.

Shreehas Tambe, CEO & Managing Director, Biocon, said: "The positive CHMP opinion for our Pertuzumab biosimilar marks an important step toward expanding access to biologic therapies for patients with HER2-positive breast cancer in Europe. As the first monoclonal antibody biosimilar to receive a positive CHMP opinion under EMA's tailored clinical development approach, it reflects an important milestone in the evolution of biosimilar science and greater regulatory confidence on advanced analytical and clinical pharmacology evidence to establish biosimilarity."

The European Commission will now proceed with the final review of the application and issue its decision. Following a positive decision, the Summary of Product Characteristics (SmPC) will be available in all official European Union languages, while the European Public Assessment Report (EPAR) will be published on the EMA website in the weeks following the decision.

Until marketing authorisation is granted by the European Commission, the product is not authorised for use in the European Union.