On 22 December 2025, R-Pharm announced that it has presented its progress on two biosimilar products at the 29th Russian Oncology Congress: Persinthia®, biosimilar to Roche’s Perjeta® (pertuzumab), for the treatment of HER2-positive breast cancer; and Arcetux®, biosimilar to Eli Lilly/Merck KgGa’s Erbitux® (cetuximab), for treatment of head and neck tumours. Both biosimilars have completed Phase III trials and R-Pharm expects they will gain registration in Russia in 2026.
Biocad already has Russian approval for a pertuzumab biosimilar. Pertuzumab biosimilars have also been approved in at least the US (Shanghai Henlius) and India (Enzene, Zydus and Intas).
Roche has recently indicated that biosimilar competition to Perjeta® (pertuzumab) is a bigger concern than it previously anticipated. Roche is also taking legal action in India to prevent biosimilar competition to Perjeta® from Zydus’ Sigrima® product, with the High Court of Delhi issuing an interlocutory judgment in July 2025.
Further pertuzumab biosimilars are under development – Sandoz and EirGenix have a commercialisation deal in place for 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 May 2023, Lupin and Enzene announced a strategic collaboration to launch Cetuxa® in India, as the first biosimilar cetuximab in that country. In January 2018, Amgen disclosed at the JP Morgan Healthcare Conference that it was in the process of developing a cetuximab biosimilar.