On 30 January 2026, a Joint Stipulation of Dismissal was filed in the US District Court for the District of New Jersey dismissing all claims in the BPCIA litigation commenced by Genentech/Roche in August 2025 in relation to Shanghai Henlius/Organon’s Poherdy® (HLX11, pertuzumab), biosimilar to Genentech/Roche’s Perjeta®. While the Joint Stipulation confirms that the parties have entered into a settlement agreement, the terms of that settlement remain confidential and no details of any planned US launch of Poherdy® have been disclosed to date.
In the legal proceedings, Genentech and Roche had alleged infringement by Henlius and Organon of 24 US patents relating to pertuzumab, pharmaceutical compositions comprising pertuzumab, methods of treatment using pertuzumab and methods of manufacturing therapeutic antibodies like pertuzumab. In response, Shanghai Henlius and Organon sought declarations of non-infringement and invalidity of the patents.
The litigation followed FDA acceptance of Henlius/Organon’s Biologics Licence Application for HLX11 in January 2025. HLX11 received FDA approval, as Poherdy® in November 2025 and was designated as interchangeable to Perjeta®. No other pertuzumab biosimilars have received US approval.
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”.
Biocad’s pertuzumab biosimilar, Pertuvia™, was approved in Russia in May 2025 and pertuzumab biosimilars have been approved in India (Enzene, Zydus and Intas). R-Pharm and Sandoz/EirGenix have pertuzumab biosimilars in their pipelines.