Russia’s Ministry of Health has approved the country’s first domestic biosimilar of Roche’s Perjeta (pertuzumab) for HER2-positive breast cancer. The new drug, named Pertuvia and developed by Russian biotech firm Biocad, marks the country’s entry into locally produced biosimilars for this therapy. Pertuvia has undergone a full cycle of preclinical and clinical testing, confirming its safety and therapeutic efficacy, the manufacturer’s press service told TASS.
Biocad claims the biosimilar demonstrates comparable clinical performance to the original, including similar safety profile, pharmacokinetics, and immunogenicity.
Pertuzumab, a monoclonal antibody, is used in combination with trastuzumab and other chemotherapeutics to treat HER2-positive breast cancer. The mechanism of its action is to block the HER2 receptor, which is present in large quantities on the surface of tumor cells and stimulates their growth. Blocking HER2 receptors disrupts the signaling pathways that drive tumor cell growth and survival, ultimately leading to the death of these cells, the company said.
HER2-positive breast cancer is an aggressive breast cancer that tests positive for a protein called human epidermal growth factor receptor 2 (HER2). In 2023, 83,151 new cases were registered in Russia, accounting fors 22.5% of the incidence of malignant neoplasms in women. It remains the leading cause of cancer-related mortality among women in Russia, representing 15.9% of female cancer deaths.
A comparative clinical trial by Biocad of its drug BCD-178 (a biosimilar of pertuzumab) and the original drug from Swiss Roche was announced back in 2022. At that time, it was reported that the study would involve 168 people and would be conducted at the X7 Clinical Research center in St. Petersburg.
Roche registered pertuzumab in Russia under the trade name Perjeta. In 2018, the company announced the registration of a new indication for the drug, which was adjuvant therapy of HER2-positive breast cancer. The company also received permission to register Phesgo (pertuzumab/trastuzumab).
