On 26 July 2026, Roche and Genentech commenced BPCIA proceedings in the US District Court in New Jersey against Biocon in relation to Biocon’s Bmab 1500, biosimilar to Genentech’s Perjeta®. The litigation arises from Biocon’s submission of an abbreviated Biologics License Application (aBLA), the date of filing of which is confidential.
Roche/Genentech allege Biocon infringes 28 US patents for inventions related to Perjeta® and various manufacturing methods for antibody production, covering pertuzumab as well as its use and manufacture. Roche and Genentech are seeking “a preliminary and/or permanent injunction” to prevent Biocon from launching any product in the US that infringes the asserted patents, and damages.
The litigation follows Genetech’s February 2026 ITC complaint against Biocon’s importation of Bmab 1500 into the US. In the ITC complaint, Genentech alleges that on 18 October 2025, Biocon imported more than 17,800 units of BMAB 1500 into the US from India before it received FDA approval.
Roche/Genentech filed BPCIA proceedings in the US District Court for the District of New Jersey in August 2025 against Shanghai Henlius and Organon in relation to their pertuzumab biosimilar, Poherdy® (FDA-approved in November 2025). Those proceedings were settled in January 2026 on confidential terms. In March 2026, Genentech commenced legal proceedings against Biocad before the Moscow Arbitration Court alleging patent infringement due to Biocad’s Pertuvia™ (approved in Russia in May 2025). Court action by Roche against Zydus regarding its pertuzumab biosimilar, Sigrima®, has been running in India since the Indian approval of the product in June 2024.