On 29 April 2026, the European Commission approved Shanghai Henlius and Organon’s Poherdy® (pertuzumab) as the first biosimilar to Genentech/Roche’s Perjeta®.
Poherdy® is indicated for use (with trastuzumab and docetaxel) in adults with HER2-positive metastatic or locally recurrent unresectable breast cancer. The approval follows the CHMP recommendation of 27 February 2026.
Under a June 2022 deal, Organon has exclusive global commercialisation rights for Henlius’ pertuzumab and denosumab biosimilars, “except for China; including Hong Kong, Macau and Taiwan”.
Roche and Genentech settled parallel BPCIA proceedings against Shanghai Henlius and Organon relating to Poherdy® in the US in January 2026. Poherdy® was approved by the FDA in November 2025.
Pertuzumab biosimilars have been approved in India and include 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) have been approved. Pertuzumab biosimilars are also under development by Sandoz and EirGenix and, in February 2026, Genentech commenced US ITC proceedings against Biocon regarding its pertuzumab biosimilar, BMAB 1500.