On 4 February 2026, R-Pharm announced it has obtained Russian marketing authorisation for the anti-cancer drug Arcetux™, biosimilar to Eli Lilly/Merck KgGa’s Erbitux® (cetuximab). This is the first biosimilar cetuximab to be approved in Russia.
Arcetux™ has been approved for two indications, local head and neck cancer treatment and metastatic colorectal cancer. Cetuximab is listed on the Russian Vital and Essential Drugs (VED) list, which allows for increased accessibility for patients.
The approval follows R-Pharm’s announcement in December 2025 at the 29th Russian Oncology Congress that Arcetux™ had completed Phase III trials.
Alkem’s Cetuxa™ was reportedly the first cetuximab biosimilar to be approved and launched globally, having been approved in India in January 2023 and launched in May 2023. Alkem’s biological arm, Enzene, entered into a strategic collaboration with Lupin in May 2023 for Indian commercialisation of Cetuxa™. Sincere Pharmaceutical/Mabpharm’s Enlituo® (cetuximab beta) was approved in China in June 2024.