On 30 June 2026, EirGenix announced that it has signed an agreement for the licensing and commercialisation of EG1206A, biosimilar to Roche’s Perjeta® (pertuzumab), in Japan. The partner to the deal has not been identified but is said to be a “leading Japanese pharmaceutical company”.
Under the agreement, EirGenix will provide CMC-related know-how and product-related information necessary for regulatory activities, while remaining responsible for product development, manufacturing, and commercial supply. The Japanese partner will lead regulatory approval activities and commercialisation in Japan.
According to EirGenix, a pharmacokinetic clinical study for EG1206A has been completed and the biosimilar has received positive feedback from both the FDA and the European Medicines Agency regarding the feasibility of an abbreviated development pathway, including the waiver of Phase 3 comparative efficacy trials.
In 2025, EirGenix entered into a global commercialisation deal with Sandoz for EG1206A which excluded Japan and a number of other countries in Asia. This followed a 2023 deal between the same companies relating to EirGenix’s trastuzumab biosimilar Herwenda® (referencing Genentech’s Herceptin®).
Henlius and Organon are leading the pertuzumab biosimilar race in major markets, with approvals of Poherdy® secured in the US, EU, and China (as Hanbeiyou®). Approvals for pertuzumab biosimilars have been granted in India for Intas’ product (December 2024), 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.