Biocon Limited has entered into a global patent settlement and licence agreement with Genentech, a subsidiary of Roche, resolving pending disputes over Pebrilzo, its biosimilar to Perjeta (pertuzumab), a biologic medicine used to treat HER2-positive breast cancer. The agreement establishes launch timelines for the drug across key international markets, including the United States, the United Kingdom and the European Union.

Under the agreement, Biocon can launch Pebrilzo in the United Kingdom and European Union in the first quarter of 2027, followed by a planned launch in the United States in the third quarter of 2028. Launches in other international markets are expected during 2026–2028, or earlier in certain circumstances. All launches remain subject to applicable regulatory approvals.

The settlement resolves patent disputes between the companies across multiple jurisdictions, including the United States and Canada. Genentech had filed a patent infringement lawsuit against Biocon in the US District Court for the District of New Jersey earlier in 2026, alleging that Biocon’s proposed biosimilar would infringe its patents. Following the settlement, the lawsuit was dismissed at Genentech’s request. The financial and other terms of the global agreement have not been disclosed.

Pebrilzo contains pertuzumab, a monoclonal antibody that targets the human epidermal growth factor receptor 2 (HER2). It is used in the treatment of HER2-positive breast cancer across multiple stages of the disease. Biosimilars are highly similar versions of approved biological medicines, developed to expand treatment options while meeting regulatory standards for quality, safety and efficacy.

The agreement is strategically significant given Perjeta’s commercial scale. According to Roche’s reported results, the reference medicine generated approximately CHF 2.97 billion (US$3.67 billion) in worldwide revenue in 2025, making it one of the company’s leading products.

The settlement strengthens Biocon’s global biosimilars portfolio and provides greater clarity on market-entry timelines for Pebrilzo. The planned launches could expand competition in the biologic breast cancer treatment market, although the timing and availability of the medicine will depend on regulatory approvals in each jurisdiction.