Company Statement: Biocon Secures Earliest Licensed Launch Dates for Pebrilzo® (bPertuzumab) Following Global Patent Settlement with Genentech

Nature of Disclosure: Regulatory filing regarding a global patent settlement and license agreement.

Key Development: Biocon Limited has entered into a global settlement and license agreement with Genentech, securing earliest licensed launch dates for Pebrilzo®, its biosimilar to the reference product Perjeta® (Pertuzumab).

Agreement Details:

  • The patent settlement agreement resolves all pending disputes between Biocon and Genentech across multiple jurisdictions including the U.S., Canada, and other countries.
  • The agreement enables Biocon to launch Pebrilzo® according to the following timeline:
  • European Union and UK: Q1 of calendar year (CY) 2027
  • United States: Q3 of calendar year (CY) 2028
  • Rest of the World (RoW) countries: During CY 2026-2028 or earlier in certain circumstances

Confidentiality: The other terms of the agreement are confidential and not disclosed.

Product Information:

  • Pebrilzo® is a biosimilar medicinal product with the active substance Pertuzumab
  • It is a monoclonal antibody that binds with high affinity and specificity to the human epidermal growth factor receptor 2 (HER2)
  • Mechanism of action: Inhibits the proliferation of tumour cells that overexpress HER2
  • Therapeutic use: Treatment of HER2-positive breast cancer across multiple disease stages

Important Notes:

  • All product launches in all countries/regions are subject to regulatory approval
  • All trademarks, registered or unregistered, are the property of their respective owners

Forward-Looking Statement: The company notes that statements are subject to risks and uncertainties that may cause actual results to differ materially from those expressed or implied. The Company undertakes no obligation to update these statements except as required by law.

Filing Details:

  • Document reference: BIO/SECL/TG/2026-27/73
  • Filed with: BSE Limited and National Stock Exchange of India Limited
  • Digital signature date: October 14, 2026 at 08:23:20 +05:30