Biocon Ltd. announced on Wednesday, October 14, that it has secured licensed launch dates for its cancer treatment biosimilar Pebrilzo following a global settlement with Genentech. According to the company's exchange filing, the two companies executed a patent settlement agreement to resolve all pending disputes between them, including in the US, Canada and other jurisdictions. The settlement and licence agreement enables Biocon to launch Pebrilzo in the first quarter of calendar year 2027 in the European Union and UK, in the third quarter of calendar year 2028 in the US, and in calendar years 2026-2028 in other 'rest of the world' countries or earlier in certain circumstances. The patent settlement outlines specific market entry windows for the biosimilar product across key geographies, with launches subject to regulatory approval in each respective country or region.
The settlement resolves patent disputes with Genentech, part of the Roche group, and reduces uncertainty surrounding the commercialisation of Pebrilzo, a proposed biosimilar to Roche's blockbuster breast cancer medicine Perjeta. According to Roche's financial disclosures, Perjeta generated global sales of around ₹2.97 billion Swiss francs in 2025, highlighting the significant market opportunity Biocon is targeting. However, competition is already emerging as the US Food and Drug Administration approved Poherdy, developed by Shanghai Henlius Biologics, as the first interchangeable biosimilar to Perjeta in November 2025. Roche's subcutaneous combination therapy Phesgo could also affect demand for standalone pertuzumab products. The revenue opportunity for biosimilar manufacturers will depend on pricing discounts, competition and the pace at which hospitals and healthcare providers adopt lower-cost alternatives.
In September 2026, the European Medicines Agency's Committee for Medicinal Products for Human Use recommended marketing authorisation for Pebrilzo, bringing the company closer to European commercialisation, subject to final approval. The settlement comes as Biocon advances its regulatory preparations and has secured a long-term pertuzumab supply contract in Brazil, strengthening its presence in the oncology biosimilars market. For Biocon, the agreement provides greater visibility on launch timelines, allowing it to plan manufacturing, supply arrangements and commercial partnerships. The company noted that other terms of the agreement are confidential, suggesting the settlement may include additional financial or commercial terms beyond the launch timeline.
