The Ministry of Health of the Russian Federation has issued a registration certificate for the first Russian biosimilar of the drug cetuximab. The medicine, under the trade name “Arcetux”, developed by the R-Pharm group of companies, is intended to replace the expensive German original “Erbitux” (Merck) in the therapy of aggressive forms of cancer.
Breakthrough in Therapy Accessibility
The new drug has become the first biosimilar of cetuximab registered in Russia and the second in the world. The medicine is a chimeric monoclonal antibody that specifically binds to the epidermal growth factor receptor (EGFR) on the surface of tumor cells. This mechanism inhibits tumor growth and prevents the appearance of metastases.
Key indications for the use of “Arcetux” include:
- Locally advanced squamous cell carcinoma of the head and neck.
- Metastatic colorectal cancer.
The drug is included in the list of Vital and Essential Drugs (VED), which guarantees its availability to patients within the framework of state procurement.
Proven Efficacy
Registration was preceded by large-scale Phase III clinical trials involving more than 250 patients with recurrent or metastatic head and neck cancer.
The results, presented at the XXIX Russian Oncology Congress in 2025, confirmed the full therapeutic equivalence of the Russian development to the original drug. The safety profile, immunogenicity, and efficacy of “Arcetux” proved to be fully comparable to the foreign analogue.
“Our cetuximab biosimilar became the first in Russia and the second in the world. We accepted this challenge and achieved an excellent result… Patients with aggressive, complex tumors must receive advanced therapy — R-Pharm works on this every day.”
— Mikhail Samsonov, Medical Director of R-Pharm Group
Economic Effect
The launch of the Russian analogue is of strategic importance for the healthcare system budget. Cetuximab is one of the most in-demand and costly drugs in oncology. According to the analytical company Headway Company, in 2025 alone, state customers purchased cetuximab worth 8.4 billion rubles.
The emergence of a local manufacturer will reduce dependence on imports in a critically important segment of drug provision and optimize state budget expenditures through competitive pricing.
