The first registration certificate for a medicinal product was obtained under an accelerated procedure.

In 2022, the so-called “accelerated” registration procedure for medicines for which there is a risk of inventory shortage was organized in Russia (read more about this phenomenon in previous articles). In December 2022, the first marketing authorization (MA) was obtained in the frame of this procedure.

The Ministry of Health of Russia approved the antitumor drug Pembroria (international non-proprietary name – Pembrolizumab). The application for registration was submitted at the beginning of July 2022. The holder of the RC is BIOCAD JSC. The entire production cycle of the drug is carried out in Russia.

Pembrolizumab is a humanized (very close to human in structure) monoclonal antibody, an inhibitor of PD-1 receptors, the blocking of which helps the body to recognize better tumor cells and fight them with its own immunity. Pembroria is indicated for the treatment of more than ten oncological diseases, including melanoma, cancer of the lung, kidney, endometrium, cervix, etc.

Pembroria is the first biosimilar to MSD’s original Keytruda, which was first approved in the US in 2014 for the treatment of advanced or inoperable melanoma. In Russia, the original drug was registered in November 2016.

BIOCAD is currently conducting three phase I and III clinical trials of Pemboria, which should be completed in 2023, 2026 and 2027. As part of the study, the pharmacokinetics and safety of the Pembroria drug in comparison with the Keytruda drug, the effectiveness of the Pembroria drug in patients with unresectable or metastatic melanoma of the skin, as well as the immunogenicity of the drug in patients who previously received therapy in the clinical trials of the company BIOCAD is being estimated.

As already noted in the general article on the accelerated procedure, fast-track registration implies a number of limitations. In this case, the holder of the registration certificate (BIOCAD company), upon receipt of complete clinical trial data on efficacy and safety, will be required to submit a dossier for reassessment of the benefit/risk ratio.

The expiration date of the registration certificate is 02.12.2023.