Biocon has secured a clearer pathway to launch its breast cancer biosimilar Pebrilzo (pertuzumab) in major regulated markets after reaching a global patent settlement with Genentech, potentially opening up a significant commercial opportunity in the oncology segment.
The agreement allows Biocon to launch the biosimilar in the European Union and the United Kingdom from the first quarter of 2027, and in the United States from the third quarter of 2028, subject to regulatory approvals.
Launches in other markets are permitted between 2026 and 2028, with provisions for earlier entry under certain conditions.
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.
Perjeta generated global sales of around 2.97 billion Swiss francs in 2025, according to Roche’s financial disclosures, highlighting the size of the market Biocon is targeting.
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However, 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.
Pertuzumab is a monoclonal antibody used to treat HER2-positive breast cancer, typically in combination with trastuzumab and chemotherapy.
Biosimilar versions could help lower treatment costs and improve patient access to expensive biologic therapies.
The settlement comes as Biocon advances its regulatory preparations.
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.
Competition, however, is already emerging.
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.
For Biocon, the agreement provides greater visibility on launch timelines, allowing it to plan manufacturing, supply arrangements and commercial partnerships.
The company has also secured a long-term pertuzumab supply contract in Brazil, strengthening its presence in the oncology biosimilars market.
While the settlement removes an important legal obstacle, the eventual financial gains will depend on regulatory clearances, market-entry timing and Biocon’s ability to secure share in an increasingly competitive segment.