On 13 November 2025, the FDA announced that it has approved Shanghai Henlius’ Poherdy™ (formerly HLX11, pertuzumab-dpzb) as an interchangeable biosimilar to Roche’s Perjeta®, including in combination with trastuzumab. Henlius’ Poherdy™ is the first pertuzumab biosimilar approved in the US.
In August 2025, Roche and its subsidiary Genentech sued Henlius in ongoing proceedings in the US District Court for New Jersey alleging infringement of patents relating to Perjeta®. The proceeding also names as a defendant Henlius’ licence partner, Organon. Henlius and Organon struck a licensing deal in June 2022 giving Organon exclusive global commercialisation rights to Henlius’ pertuzumab and denosumab biosimilars, “except for China; including Hong Kong, Macau and Taiwan”.
A day before the FDA announced approval of Poherdy™, Sandoz and EirGenix entered into a global licensing agreement for EirGenix’s pertuzumab biosimilar, giving Sandoz exclusive commercialisation rights worldwide, excluding certain countries in Asia.