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Biocon Secures Patent Settlement, Clears Path for Pebrilzo Biosimilar Launch

Biocon has reached a global patent settlement with Genentech, allowing its pertuzumab biosimilar Pebrilzo to be launched in the EU, UK, and later the US, pending regulatory approval.

Biocon has cleared a major patent hurdle for its pertuzumab biosimilar, Pebrilzo, after a worldwide settlement with Genentech, a Roche subsidiary. The agreement grants Biocon the right to introduce Pebrilzo in the European Union and United Kingdom from the first quarter of 2027 and in the United States from the third quarter of 2028, subject to final regulatory clearance. It also permits launches in additional markets between 2026 and 2028, with provisions for earlier entry under specific circumstances.

The settlement ends ongoing patent disputes and follows a recommendation by the European Medicines Agency’s Committee for Medicinal Products for Human Use. While the market for pertuzumab is sizable—Roche’s Perjeta generated roughly 2.97 billion Swiss francs in 2025—Biocon will face competition from other biosimilars like Poherdy and Roche’s sub-cutaneous combination therapy Phesgo. The company has also secured a long-term pertuzumab supply contract in Brazil, bolstering its oncology biosimilar portfolio.

Why it matters

The deal could lower breast-cancer treatment costs and expand patient access to biosimilar therapies worldwide.

In this story

Pebrilzopertuzumabbiosimilarpatent settlementbreast cancerRocheGenentechEuropean Medicines AgencyFDAmarket competition
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