Biocon Biologics' pertuzumab biosimilar, Pebrilzo, has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA). This significant development moves the Bengaluru-based company closer to launching its HER2-positive breast cancer therapy in the European Union.
Pebrilzo, a 420 mg concentrate solution for infusion, is specifically intended for the treatment of HER2-positive breast cancer across multiple stages of the disease. The CHMP's recommendation follows a thorough review of a marketing authorization application submitted by Biocon Biologics Ireland, an indirect wholly-owned subsidiary of Biocon Biologics.
This positive opinion is particularly noteworthy for Biocon because Pebrilzo represents the first monoclonal antibody biosimilar to receive such a recommendation under the EMA’s tailored clinical development approach.
In simpler terms, a biosimilar is a biological medicine that is highly similar to an already approved biological drug. It demonstrates no meaningful differences in its quality, safety, or effectiveness compared to the original. Biocon confirmed that its application included detailed laboratory studies and comprehensive clinical data, all comparing Pebrilzo with the original medicine. These studies consistently showed the two products to be highly similar, with no clinically meaningful differences in quality, safety, or efficacy.
“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,” stated Shreehas Tambe, CEO and managing director of Biocon. He further added that this recommendation reflects greater regulatory confidence in using detailed laboratory and clinical data to establish the comparability of a biosimilar to its original biological medicine.
Pertuzumab itself is a biological drug utilized in treating specific types of breast cancer where the cancer cells exhibit high levels of a protein known as HER2. Pebrilzo is proposed for use in conjunction with trastuzumab and chemotherapy for adults diagnosed with HER2-positive locally advanced, inflammatory, or early-stage breast cancer at a high risk of recurrence. It is also suggested for use with trastuzumab and docetaxel in certain patients with metastatic or locally recurrent breast cancer that cannot be surgically treated.
It is important to note that the CHMP opinion does not equate to a final marketing authorization in the European Union. The application will now advance to the European Commission for its ultimate review and decision. Until that decision is officially issued, Pebrilzo is not authorized for use within the EU.
For Biocon, this regulatory milestone further enhances its expansive global biosimilars portfolio. The company currently commercializes 12 biosimilar products and maintains a robust research and development pipeline featuring more than 20 biosimilar assets, alongside GLP-1 peptides and other complex generics. Biocon operates across over 120 countries, supported by seven manufacturing sites and three R&D facilities.
Should the European Commission grant approval, Pebrilzo will then be positioned to move towards commercial launch in the EU, subject to all applicable regulatory and market requirements.