The First Russian Biosimilar of Breast Cancer Drug Approved by the Ministry of Health

"Pertuvia" — a Russian Development to Combat an Aggressive Form of Oncology

The Ministry of Health of Russia has registered the first domestic biosimilar of the drug pertuzumab — "Pertuvia", developed by Biocad. This is a significant event for the Russian pharmaceutical market, as the drug is intended for the therapy of HER2-positive breast cancer — one of the most aggressive forms of oncology.

Pertuzumab, the original Swiss drug, is a monoclonal antibody that blocks the HER2 receptor, which is present in excess on the surface of tumor cells. This disrupts their growth mechanism and leads to their death. "Pertuvia" has undergone a full cycle of preclinical and clinical trials, confirming comparability with the original in terms of efficacy, safety, and immunogenicity. Biosimilars are not just copies, but high-tech products that require deep scientific study.

HER2-positive breast cancer is diagnosed in every fifth patient with this disease. In 2023, 83,151 new cases were identified in Russia, which is 22.5% of all malignant neoplasms in women.

Earlier, in April 2025, the Ninth Arbitration Court of Appeal recognized the uniqueness of another Russian anticancer drug — "Afotid", which has no global analogues.

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Sources
Vedomosti

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