Genentech and Biocon Settle Pertuzumab Biosimilar BPCIA Litigation
On October 14, 2026, the U.S. District Court for the District of New Jersey entered an order dismissing without prejudice all claims in Genentech Inc. and Hoffmann-La Roche Inc.’s BPCIA litigation against Biocon Biologics Inc. concerning its proposed pertuzumab biosimilar. The same day, Biocon announced that it had entered into a global patent settlement and license agreement with Genentech concerning PEBRILZO®, its proposed biosimilar to Genentech’s PERJETA®. According to Biocon, the agreement resolves pending disputes between the companies in the United States, Canada, and other jurisdictions.
As we previously reported, Genentech and Hoffmann-La Roche filed the action against Biocon on July 29, 2026, alleging infringement of 28 patents.
Under the settlement agreement, Biocon may launch PEBRILZO® in the United States in the third quarter of 2028, in the European Union and United Kingdom in the first quarter of 2027, and in other markets during 2026–2028, or earlier in certain circumstances. Launches in all markets remain subject to regulatory approval. Biocon describes the agreed dates as the “earliest licensed launch dates for PEBRILZO®.” The remaining terms of the agreement are confidential.
The settlement follows the resolution earlier this year of Genentech’s BPCIA litigation against Shanghai Henlius and Organon concerning another PERJETA® biosimilar, POHERDY® (pertuzumab-dpzb). That action was dismissed with prejudice on January 30, 2026, following a confidential settlement.
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