Biocon’s wholly-owned subsidiary, Biocon Biologics, has received a positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP). This recommendation is for the marketing authorization of its Pertuzumab biosimilar, Pebrilzo®, for HER2-positive breast cancer. This marks a significant milestone as the first biosimilar monoclonal antibody to receive such an opinion under EMA’s tailored clinical development approach, paving the way for potential market approval in the European Union.
Biocon’s Pertuzumab Biosimilar Receives Key EMA Recommendation
Biocon Biologics, a subsidiary of Biocon Limited, announced on September 21, 2026, that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion. This recommendation is for the granting of a marketing authorization to its Pertuzumab biosimilar, marketed under the brand name Pebrilzo®. The biosimilar is indicated for the treatment of HER2-positive breast cancer across multiple disease stages.
Significant Regulatory Milestone
The positive CHMP opinion follows a thorough review of the marketing authorization application submitted by Biocon Biologics Ireland Limited. This development is particularly noteworthy as it represents the first monoclonal antibody biosimilar to receive a positive CHMP opinion under the EMA’s tailored clinical development approach. Shreehas Tambe, CEO & Managing Director, Biocon, highlighted this as a critical step towards expanding access to biologic therapies for patients in Europe and a testament to the evolving science of biosimilars and enhanced regulatory confidence.
Next Steps and Product Information
The European Commission will now undertake a final review of the application, after which it will issue its decision. Following a positive decision, the Summary of Product Characteristics (SmPC) and the European Public Assessment Report (EPAR) will become available. It is important to note that until marketing authorization is officially granted by the European Commission, Pebrilzo® is not authorized for use in the European Union. Pebrilzo® is a biosimilar medicinal product with Pertuzumab as its active substance, designed to target HER2-positive tumors.
About the Product and Biocon
Pebrilzo® is indicated for use in combination with Trastuzumab and chemotherapy for the neoadjuvant treatment of adult patients with HER2-positive breast cancer at high risk of recurrence, as well as in adjuvant treatment for early-stage patients. It is also indicated for HER2-positive metastatic or locally recurrent unresectable breast cancer. Extensive analytical characterization and comparative clinical data have demonstrated that Pebrilzo® is highly similar to the reference biologic, with no clinically meaningful differences in quality, safety, or efficacy.
Biocon Limited is a global biopharmaceutical company focused on providing affordable, life-changing medicines. Headquartered in Bengaluru, India, Biocon addresses critical healthcare challenges through biosimilars and generics. The company operates across more than 120 countries and has a diversified portfolio in areas such as diabetes, oncology, and immunology.
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