R-Pharm has received marketing authorization from the Russian Ministry of Health for Persintia, a biosimilar of the cancer drug pertuzumab. The original drug, Perjeta, is produced by Roche.
In a Phase III clinical trial involving approximately 250 patients, the biosimilar demonstrated non-inferior efficacy and a comparable safety profile to the originator drug, the company emphasized.
Pertuzumab is a monoclonal antibody intended for the treatment of HER2-positive breast cancer. The antibody binds to the human epidermal growth factor receptor 2 (HER-2) on the surface of tumor cells and blocks it. The drug is part of treatment regimens that allow for better surgical outcomes and reduced risk of recurrence in early stages, as well as increased lifespan and improved quality of life for patients, GxP News was told by the R-Pharm press service, noting that pertuzumab is included in Russia’s list of vital and essential drugs (VED).
Persintia is the second biosimilar of Perjeta. The first, Pertuvia, was registered in May 2025 by OOO PK-137, a 100% subsidiary of Biocad. These drugs are presented as a concentrate for solution for infusion. According to the State Register of Medicinal Products, Roche’s portfolio in Russia also includes the drug Phesgo (pertuzumab + trastuzumab) in the form of a solution for subcutaneous injection.