Biocon’s Pertuzumab Biosimilar Receives Positive EMA CHMP Opinion Under New Tailored Clinical Approach
Biocon Biologics’ pertuzumab biosimilar, Pebrilzo®, has received a positive recommendation from the EMA’s CHMP, marking the first monoclonal antibody biosimilar to receive a positive CHMP opinion under the agency’s tailored clinical development approach.
Biocon Biologics 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 recommending marketing authorization for its pertuzumab biosimilar, Pebrilzo®, in the European Union.
The product is proposed as a 420 mg concentrate for solution for infusion and is intended for use in the treatment of HER2-positive breast cancer across multiple disease stages.
The marketing authorization application was submitted by Biocon Biologics Ireland Limited, an indirect wholly owned subsidiary of Biocon Biologics.
A milestone for the tailored clinical approach
According to Biocon, Pebrilzo® is the first monoclonal antibody biosimilar to receive a positive CHMP opinion under the EMA’s tailored clinical development approach.
The approach places greater emphasis on a comprehensive demonstration of biosimilarity using advanced analytical characterization and clinical pharmacology data, with the extent of clinical studies tailored to the scientific evidence available for a particular biosimilar.
For Pebrilzo®, Biocon reported that extensive orthogonal structural and functional analytical characterization, combined with comparative clinical pharmacokinetic data, demonstrated a high degree of similarity to the reference biologic.
The company stated that the evidence showed no clinically meaningful differences in quality, safety, or efficacy between the biosimilar and its reference product.
Proposed use in HER2-positive breast cancer
Pertuzumab is a monoclonal antibody targeting human epidermal growth factor receptor 2 (HER2). By binding to HER2, it interferes with signaling involved in the proliferation of HER2-overexpressing tumor cells.
Under the proposed European indication, Pebrilzo® would be used in combination with trastuzumab and chemotherapy for the neoadjuvant treatment of adults with HER2-positive, locally advanced, inflammatory, or early-stage breast cancer at high risk of recurrence.
It would also be used in the adjuvant treatment of adults with HER2-positive early breast cancer at high risk of recurrence.
For HER2-positive metastatic or locally recurrent unresectable breast cancer, the proposed indication includes use in combination with trastuzumab and docetaxel in patients who have not previously received anti-HER2 therapy or chemotherapy for metastatic disease.
What happens next?
The CHMP opinion is an important regulatory milestone, but it is not yet a marketing authorization.
The application will now proceed to the European Commission, which will make the final decision on whether to grant marketing authorization in the European Union.
If the European Commission grants authorization, the product’s Summary of Product Characteristics (SmPC) will become available in all official EU languages, and the European Public Assessment Report (EPAR) will subsequently be published by the EMA.
Biocon has emphasized that Pebrilzo® is not authorized for use in the European Union until the European Commission grants marketing authorization.
Why this matters for biosimilar development
The recommendation represents a notable development in the regulatory evolution of biosimilars, particularly for complex monoclonal antibodies.
The case illustrates how high-resolution analytical characterization and pharmacokinetic evidence can play a central role in establishing biosimilarity, potentially allowing clinical development programs to be designed according to the scientific characteristics and residual uncertainties associated with an individual product.
For Biocon Biologics, the decision also adds another asset to its growing global biosimilar portfolio and reinforces its focus on oncology and other areas of high unmet medical need.
Source: Biocon Limited press release, September 21, 2026. https://www.biocon.com/biocons-pertuzumab-becomes-first-biosimilar-to-secure-ema-chmp-approval-recommendation-under-new-tailored-clinical-approach/
