Biocon Achieves Positive CHMP Opinion for Pertuzumab Biosimilar, A First Under EMA’s New Clinical Approach

Biocon Secures Groundbreaking CHMP Approval for Biosimilar Against HER2-Positive Breast Cancer

Biocon Biologics Limited, a wholly owned subsidiary of Biocon Limited (BSE: 532523) (NSE: BIOCON), has announced a milestone development for its biosimilar of pertuzumab, named Pebrilzo®. On September 22, 2026, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a favorable opinion recommending the market authorization for this biosimilar aimed at treating HER2-positive breast cancer in various stages of the disease.

This positive CHMP opinion comes after an extensive evaluation of the marketing authorization application submitted by Biocon Biologics Ireland Limited—an indirect, wholly-owned subsidiary of Biocon Biologics Limited. Shreehas Tambe, the Managing Director of Biocon, recognized that this approval is a significant step forward in expanding access to biological treatments for patients with HER2-positive breast cancer in Europe.

This achievement marks the first time a monoclonal antibody biosimilar has received a positive CHMP opinion under the EMA's new clinical approach for biosimilar approvals. The decision underscores the growing confidence of regulatory authorities in advanced analytical data and clinical pharmacology studies that establish biosimilarity.

Following this favorable opinion, the European Commission will move forward with the final assessment of the application before making a final decision. If approved, the product characteristics summary (SmPC) will be available in all official languages of the European Union, and the European public assessment report (EPAR) will be published on the EMA’s website in the subsequent weeks. However, until the European Commission grants market authorization, Pebrilzo® is not allowed to be marketed in the EU.

About Pebrilzo®

Pebrilzo® is a biosimilar containing the active substance pertuzumab, a monoclonal antibody with a high affinity and specificity for the HER2 (Human Epidermal Growth Factor Receptor 2) receptor. Its mechanism of action inhibits the proliferation of tumor cells that overexpress HER2. It is intended for use in combination with trastuzumab and chemotherapy for the neoadjuvant treatment of adult patients with locally advanced, inflammatory, or early-stage HER2-positive breast cancer at high risk of recurrence. Moreover, it is indicated in the adjuvant treatment of patients with early-stage HER2-positive breast cancer at high risk of recurrence.

Additionally, Pebrilzo® is designed to be administered together with trastuzumab and docetaxel in adult patients with metastatic or locally recurrent HER2-positive breast cancer who have not received prior anti-HER2 treatment or chemotherapy for their metastatic disease. A comprehensive program exploring structural and functional analytical characterization, alongside comparative clinical pharmacokinetic data, demonstrated that Pebrilzo® exhibits high similarity to the reference biological drug without clinically relevant differences in quality, safety, or efficacy.

About Biocon Limited

Biocon Limited (BSE: 532523) (NSE: BIOCON) is a global biopharmaceutical company dedicated to providing affordable medicines that enhance the lives of patients worldwide. Headquartered in Bengaluru, India, Biocon addresses some of the world’s most pressing healthcare challenges in chronic and non-communicable diseases through a wide array of biosimilars and generic drugs marketed on various scales across multiple markets. The company focuses on therapeutic areas with high medical need, including diabetes, oncology, obesity, cardiovascular diseases, immunology, ophthalmology, and bone health. Biocon has made significant advancements in the biosimilars sector through several pioneering innovations. To date, the company has launched 12 biosimilars and over 30 generic drugs globally, boasting a research portfolio comprising more than 20 biosimilar programs alongside GLP-1 peptides and other complex generic medications under development.

With an integrated model that covers the entire value chain—from R&D to patient access—Biocon encompasses R&D, manufacturing, and marketing capabilities to ensure a reliable and sustainable supply of medicines. The company operates in over 120 countries, with seven manufacturing sites, three R&D centers, and 18 offices worldwide, employing over 9,500 individuals. For four consecutive years, Biocon has been recognized in the SP Global Sustainability Yearbook, highlighting its commitment to responsible and sustainable growth. For more information, visit www.biocon.com and follow us on social media: Twitter @bioconlimited, LinkedIn Biocon.