Date: September 21, 2026

Regulatory Approval Update

Biocon Biologics Limited, a wholly-owned subsidiary of Biocon Limited, announced 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.

Product Details

  • Product Name: Pebrilzo® (420 mg concentrate solution for infusion)
  • Therapeutic Area: HER2-positive breast cancer treatment across multiple disease stages
  • Indications:
  • Neoadjuvant treatment in combination with Trastuzumab and chemotherapy for adult patients with HER2-positive, locally advanced, inflammatory, or early-stage breast cancer at high risk of recurrence
  • Adjuvant treatment in combination with Trastuzumab and chemotherapy for adult patients with HER2-positive early breast cancer at high risk of recurrence
  • Treatment in combination with Trastuzumab and Docetaxel for adult patients with HER2 positive metastatic or locally recurrent unresectable breast cancer who have not received previous anti-HER2 therapy or chemotherapy

Regulatory Process

  • Marketing authorization application was submitted by Biocon Biologics Ireland Limited (formerly Biosimilar Collaborations Ireland Limited), an indirect wholly-owned subsidiary
  • The European Commission will now proceed with the final review and issue its decision
  • Following positive decision, Summary of Product Characteristics (SmPC) will be available in all official EU languages
  • European Public Assessment Report (EPAR) will be published on EMA website
  • Until marketing authorization is granted, the product is not authorized for use in the European Union

Significance of Approval

  • First monoclonal antibody biosimilar to receive positive CHMP opinion under EMA's tailored clinical development approach
  • Reflects regulatory confidence on advanced analytical and clinical pharmacology evidence to establish biosimilarity
  • Extensive orthogonal, state-of-the-art structural and functional analytical characterization demonstrated high similarity to reference biologic
  • No clinically meaningful differences in quality, safety, or efficacy established

Management Commentary

Shreehas Tambe, CEO & Managing Director, Biocon, stated: \"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. As the first monoclonal antibody biosimilar to receive a positive CHMP opinion under EMA's tailored clinical development approach, it reflects an important milestone in the evolution of biosimilar science and greater regulatory confidence on advanced analytical and clinical pharmacology evidence to establish biosimilarity.\"

Company Background

Biocon Limited is a global biopharmaceutical company focused on providing affordable, life-changing medicines to patients worldwide. The company has:

  • Commercialized 12 biosimilar products and 30+ generic formulations globally
  • Robust R&D pipeline of 20+ biosimilar assets, GLP-1 peptides, and other complex generics
  • Operations in more than 120 countries
  • Seven manufacturing sites, three R&D sites, 18 offices worldwide
  • Workforce of over 9,500 employees
  • Included in S&P Global Sustainability Yearbook 2026 for fourth consecutive year