Biocon Limited has entered into a global patent settlement and licence agreement with Genentech, a member of the Roche Group, resolving pending disputes over Pebrilzo® (bPertuzumab), its biosimilar version of Perjeta® (pertuzumab), a biologic medicine used in the treatment of HER2-positive breast cancer.
The agreement establishes the earliest licensed launch dates for Pebrilzo in major markets, including the European Union, the United Kingdom and the United States. The settlement covers pending disputes between the companies in the US, Canada and other jurisdictions. The financial and other specific terms of the agreement have not been disclosed.
Why Did the Patent Dispute Happen?
The dispute arose from Biocon's plans to commercialise Pebrilzo, a biosimilar of Perjeta, which was developed by Genentech. Biosimilars are highly similar versions of approved biological medicines and may offer additional treatment options once they receive the necessary regulatory approvals and can legally enter the market.
Genentech and its parent company, Roche, pursued patent litigation against Biocon over its proposed pertuzumab biosimilar in the United States. In July 2026, Genentech filed a lawsuit in the US District Court for the District of New Jersey, alleging infringement of 28 patents associated with Perjeta and its related technology.
The case, Genentech Inc. v. Biocon Biologics Inc., was registered under case number 2:26-cv-09585. The dispute concerned patent rights and Biocon's proposed entry into the US market with its biosimilar product. The settlement resolves the pending disputes covered by the agreement without requiring the companies to continue litigating those matters.
What Is Pebrilzo (Pertuzumab)?
Pebrilzo is a biosimilar medicinal product containing pertuzumab as its active substance. Pertuzumab is a monoclonal antibody that binds to the human epidermal growth factor receptor 2 (HER2).
HER2 is a protein involved in cell growth. In certain breast cancers, HER2 is overexpressed, contributing to tumour growth. Pertuzumab binds to HER2 and interferes with receptor pairing and associated growth signalling, helping inhibit the proliferation of tumour cells.
Perjeta is used in the treatment of HER2-positive breast cancer across different disease stages and treatment settings. Pertuzumab is generally used in combination with other anticancer medicines according to the approved indication and treatment regimen.
Why Is This Settlement Important for Biocon?
The agreement provides greater clarity regarding the timing of Pebrilzo's potential entry into major international markets. Resolving the covered patent disputes can reduce legal uncertainty surrounding commercialisation, while the licensed launch dates give the company a defined timeline for market preparation.
The European Union and UK launch window begins in the first quarter of 2027, while the US launch window is scheduled for the third quarter of 2028. The settlement also addresses other markets within the 2026–2028 period, subject to the agreement's terms and local regulatory requirements.
For the broader biosimilars industry, the case highlights how patent litigation and licensing agreements can influence when biosimilar medicines enter regulated markets. Even where a biosimilar has progressed through regulatory review, patent disputes can affect the timing of commercial launch.
