Biocon Ltd has entered into a global settlement and license agreement with US based biotech major Genentech for its drug Pebrilzo, a biosimilar or copycat version of Genentech's breast cancer drug Perjeta (Pertuzumab).
Biocon and Genentech executed the patent settlement agreement to resolve all pending disputes between the companies, including in the U.S., Canada, and other jurisdictions. This global patent settlement and license agreement enables Biocon to launch Pebrilzo in Q1 of calendar year (CY) 2027 in the European Union and UK, Q3 of CY 2028 in the U.S., and in CY 2026-2028 in other Rest of the World (RoW) countries or earlier in certain circumstances.
The other terms of the agreement are confidential, said a company release.
Market research estimates the global Perjeta and pertuzumab-related market size at roughly $4.30 billion to $4.54 billion. It had approximately $3.5 billion plus sales in FY25 and was experiencing a year-over-year decline of about 13% as patients transition to Roche's fixed-dose combination therapy, Phesgo, said sources.
Pebrilzo is a biosimilar medicinal product and the active substance is Pertuzumab, a monoclonal antibody that binds with high affinity and specificity to the human epidermal growth factor receptor 2 (HER2), inhibiting the proliferation of tumour cells that overexpress HER2. Pebrilzo® is used for the treatment of HER2‑positive breast cancer across multiple disease stages.
Biocon has invested over ₹10,000 crore in research and development for biosimilars and is betting its next phase of growth on biosimilars targeting blockbuster biologics that will lose patent protection over the next decade. About 55 biologics with annual sales above $1 billion are expected to lose exclusivity between 2022 and 2032. The cumulative market opportunity is estimated at $270 billion, and of this, cancer drugs constitute about $75 billion.
In 2014, Biocon became the first Indian company to launch a biosimilar for trastuzumab (Roche’s blockbuster breast cancer drug Herceptin). Today, the product commands over 23% market share in the U.S. and Europe. Its pegfilgrastim Fulphila – biosimilar for Amgen’s brand Neulasta used to control infection during chemotherapy - has captured around 25% share in these markets. The oncology portfolio now includes around 18 molecules, including pipeline assets.