Biocon Secures Early Global Launch Dates for Pebrilzo Following Genentech Settlement

Biocon Limited has entered into a global patent settlement and license agreement with Genentech, successfully securing the earliest licensed launch dates for Pebrilzo, its biosimilar referencing Perjeta (Pertuzumab). This comprehensive agreement resolves all pending legal and patent disputes between the two companies across multiple key jurisdictions, including the United States and Canada.

Under the terms of the global settlement, Biocon is permitted to launch Pebrilzo in the European Union and the United Kingdom in the first quarter of calendar year 2027, followed by a United States launch in the third quarter of calendar year 2028. Additionally, the agreement clears rollouts across other Rest of the World countries between 2026 and 2028, or earlier under specific circumstances. All other commercial and financial terms of the settlement remain confidential.

Pebrilzo functions as a critical biosimilar medicinal product containing Pertuzumab as its active substance. Pertuzumab is a specialized monoclonal antibody that binds with high affinity and specificity to human epidermal growth factor receptor 2, effectively inhibiting the proliferation of tumor cells that overexpress HER2. The medicine is indicated for treating HER2-positive breast cancer across various disease stages. Biocon notes that future product rollouts across all designated regions remain strictly subject to necessary regulatory approvals, and forward-looking statements involve inherent risks and uncertainties that could cause actual outcomes to differ materially.