Type of medical product:

Protein based

Novelty:

Biosimilar

Field:

Oncology

Status:

Preclinical trials in vivo

The agent is a humanized monoclonal antibody against transmembrane receptors of human type-2 epidermal growth factor HЕR–2/neu and a biosimilar of Herceptin® (Roche, Switzerland). 

HER2 receptor is one of the most important molecular markers in breast cancer (BC). In normal settings HER2 receptor is found at the surface of many cells. Approximately every 4th woman with BC shows elevated levels of this protein in tumor cells vs. normal tissues. Increased expression is associated with HER2/neu gene amplification. Excessive amount of the receptor on the surface of the cancer cells indicates a highly aggressive form of breast cancer . Anti-receptor antibodies shows antiproliferative activity and induce apoptosis in cancer cells bearing HER2 on the surface due to р27 protein activation and impaired dimerization of HER2 with HER3. 

Breast cancer is the most prevalent cancer in Russia and in the world with a steady trend to increasing incidence. The breast cancer risk is observed in women between the ages of 30 and 60 with the peak between 50 and 60 years of age, wich comprise a considerable part of active and productive age population.