On 2 February 2026, R-Pharm announced that the Russian Ministry of Health has approved Persinthia™, biosimilar to Genentech/Roche’s Perjeta® (pertuzumab), for the treatment of HER2-positive breast cancer. The approval follows R-Pharm’s announcement in December 2025 at the 29th Russian Oncology Congress that Persinthia™ had completed Phase III trials.
Persinthia™ is the second pertuzumab biosimilar approved in Russia, following approval of Pertuvia™ in May 2025 by OOO-PK-137, a subsidiary of Biocad.
Shanghai Henlius/Organon’s Poherdy®/HLX11 (pertuzumab) was approved in the US in November 2025. In January 2026, Henlius, Organon, Genentech and Roche settled BPCIA litigation in relation to the biosimilar.
Sandoz and EirGenix have a commercialisation deal in place for pertuzumab biosimilar EG1206A (November 2025) and received positive feedback from both the FDA and the European Medicines Agency, confirming that the product qualifies for an abbreviated development pathway allowing for the waiver of Phase III comparative efficacy trials.
In India, Enzene’s pertuzumab biosimilar was launched in September 2025 and is being marketed by Enzene’s parent company, Alkem Laboratories, as Pertuza®, and Hetero Healthcare as Perzea®. Zydus’ Sigrima™ was approved in India in September 2024, but is subject to ongoing litigation. Intas received approval for its pertuzumab biosimilar in December 2024, subject to submission of further studies.