Bengaluru, Karnataka, India, September 21, 2026
Biocon Biologics Limited, a wholly owned subsidiary of Biocon Limited, has reached a significant milestone in biosimilar development after the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion recommending marketing authorization for the company’s pertuzumab biosimilar, Pebrilzo®. The recommendation covers 420 mg concentrate for solution for infusion for the treatment of HER2-positive breast cancer across multiple disease settings. The EMA confirmed that Pebrilzo is highly similar to its reference medicine, pertuzumab, with comparable quality, safety and efficacy. The decision also marks the first biosimilar medicine recommended for approval under the EMA’s new tailored clinical approach, highlighting the growing role of advanced analytical and clinical pharmacology evidence in biosimilar development.
First Biosimilar Under EMA Tailored Clinical Approach
The CHMP positive opinion represents an important development in the European biosimilar regulatory pathway. Biocon states that its pertuzumab biosimilar is the first monoclonal antibody biosimilar to receive a positive CHMP opinion under the tailored clinical development approach. The approach places greater emphasis on a comprehensive demonstration of biosimilarity through advanced analytical characterization and clinical pharmacology data, with the extent of clinical evidence tailored according to the scientific characteristics of the product and the available evidence. For Biocon, the milestone demonstrates how modern biosimilar development strategies can combine high-resolution analytical testing, structural and functional characterization and comparative pharmacokinetic evaluation to establish similarity to an established biologic.
The EMA describes Pebrilzo as a biosimilar medicinal product containing pertuzumab, a monoclonal antibody that binds specifically to human epidermal growth factor receptor 2 (HER2). HER2 is overexpressed in a subset of breast cancers and represents an established therapeutic target. According to the EMA, the available data demonstrate that Pebrilzo is highly similar to the reference product Perjeta, with comparable quality, safety and efficacy.
Pebrilzo Targets HER2-Positive Breast Cancer
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The recommended indications cover several important settings in HER2-positive breast cancer. Pebrilzo is intended for use with trastuzumab and chemotherapy in the neoadjuvant treatment of adult patients with HER2-positive, locally advanced, inflammatory or early-stage breast cancer at high risk of recurrence. It is also recommended for adjuvant treatment of adults with HER2-positive early breast cancer who have a high risk of recurrence. In metastatic or locally recurrent unresectable disease, Pebrilzo is recommended in combination with trastuzumab and docetaxel for adults who have not previously received anti-HER2 therapy or chemotherapy for metastatic disease.
Biocon reports that the development program included extensive orthogonal structural and functional analytical characterization, together with comparative clinical pharmacokinetic data. These assessments supported the conclusion that the biosimilar is highly similar to the reference biologic without clinically meaningful differences in quality, safety or efficacy. Such evidence is central to establishing biosimilarity and supports the regulatory assessment of the product for its proposed breast cancer indications.
European Commission Decision Is Next
Following the positive CHMP opinion, the application moves to the European Commission, which will make the final decision on marketing authorization. Until that decision is issued, Pebrilzo is not authorized for use in the European Union. If authorization is granted, the product information, including the Summary of Product Characteristics, will be made available in the official languages of the European Union, while the European Public Assessment Report will subsequently be published by the EMA.
The milestone adds to the development of biosimilar access to complex biologic medicines in Europe and highlights the evolving regulatory framework for demonstrating biosimilarity. For Biocon, the positive CHMP opinion represents progress for its pertuzumab biosimilar program and its broader biologics portfolio. For the European oncology market, the potential authorization of Pebrilzo could add another biosimilar option to the treatment landscape for patients with HER2-positive breast cancer, subject to the European Commission’s final decision.
Source: Biocon press release
