The R-Pharm Group has received marketing authorization from the Russian Ministry of Health for the anti-cancer drug Artsetux (cetuximab), the first Russian and the second global biosimilar of Erbitux from the German pharmaceutical manufacturer Merck KGaA. This was reported to GxP News by the press service of R-Pharm.
Cetuximab is used in the treatment of locally advanced metastatic head and neck cancer and metastatic colorectal cancer. It is a monoclonal antibody that binds to the epidermal growth factor receptor (EGFR) on the surface of tumor cells. Blocking EGFR inhibits cell growth, preventing tumor progression and metastasis.
The biosimilarity of “Artsetux” and the originator drug was proven in a Phase III clinical trial involving over 250 patients with recurrent or metastatic head and neck cancer. “The study results confirm the non-inferior efficacy and comparable safety profile of the biosimilar,” the statement notes.
Cetuximab is available on the market as a solution for infusion. It is included in the list of vital and essential drugs (VED).
