On 29 May 2026, Shanghai Henlius announced China’s National Medical Products Administration (NMPA) has approved its pertuzumab (HLX11/Hanbeiyou®, marketed as Poherdy® in the US and Europe), biosimilar to Roche’s Perjeta® (pertuzumab). Hanbeiyou® is approved for all Perjeta® indications.
HLX11/Poherdy® was the first pertuzumab biosimilar approved in the US (November 2025) and EU (April 2026). In the US, a BPCIA patent challenge by Genentech/Roche against Henlius/Organon regarding Poherdy® was settled in January 2026 on confidential terms, with no details of any planned US launch of Poherdy® being disclosed to date.
Organon has exclusive global commercialisation rights to HLX11, “except for China; including Hong Kong, Macau and Taiwan”, under a June 2022 deal.
Pertuzumab biosimilars have been approved in India, including Intas’ biosimilar (December 2024, subject to submission of further studies), Zydus’ Sigrima™ (June 2024, subject to ongoing litigation) and Enzene’s Pertuza®/Perzea® (launched September 2025). In Russia, Biocad’s Pertuvia™ (May 2025) and R-Pharm’s Persinthia™ (February 2026) are approved. Pertuzumab biosimilars are also under development by Sandoz and EirGenix. In February 2026, Genentech commenced US ITC proceedings against Biocon regarding its pertuzumab biosimilar, BMAB 1500.