Pembrolizumab was approved for medical use in 2014 (USA). Since then, this product, together with other immune checkpoint inhibitors, have radically changed the approach to cancer treatment. Due to emerging data of an unprecedentedly high number of clinical studies of pembrolizumab, new indications have been approved. At the time of writing this Protocol, the indications approved in the India, Russian Federation, EU, USA and other countries include melanoma, NSCLC, head and neck cancer, classical Hodgkin lymphoma, urothelial cancer, microsatellite instability-high cancer, cervical cancer, renal cell carcinoma, endometrial cancer, colorectal cancer, triple negative breast cancer. Moreover, it should be noted that the results of more than a thousand other clinical studies of this drug are expected, which will lead to the registration of new indications in the following years.

Noteworthy, pembrolizumab is already indicated for most cancer patients. Considering that malignancies are one of the leading causes of death among all diseases worldwide, including in Russia, the importance of pembrolizumab for the population cannot be overestimated. The main barrier for the widespread use of pembrolizumab is its cost. It should be noted that most patients who need this drug cannot receive it at this time. This trend is observed globally for all novel anti-tumor drugs. The only effective solution for this problem is to develop biosimilars that ensure the same efficacy and safety at a lower cost and thus can be made available to a wider population.

Based on the above, it can be concluded that the development of pembrolizumab biosimilar is justified and will meet the clinical need of the population for a highly effective anti-cancer therapy.

This study aimed at confirming the biosimilarity of BCD-201 and Keytruda when used as firstline therapy in subjects with unresectable or metastatic skin melanoma in terms of the efficacy and safety.