Russia registers its first domestically manufactured biosimilar of infliximab

| By | Biocad, Biosimilars, Drug Registration

The Russian Ministry of Health has registered BCD-055, the first Russian-made biosimilar of infliximab developed by BIOCAD, a biotech company. The drug will help to significantly reduce the cost of therapy of rheumatoid arthritis and psoriasis for patients in Russia.

BIOCAD was developing the local biosimilar of infliximab since 2013. By March 2017, it completed the main stage of clinical trials and prepared a complete registration dossier.

“BCD-055 is the fourth biosimilar of monoclonal antibodies developed by our company. There is no doubt that it will have a great future because, at all phases of trials, BCD-055 demonstrated that it was  equivalent to the original drug,” said Roman Ivanov, the Vice President R&D at BIOCAD. “Many doctors regretted that the clinical trials were coming to an end, as it meant stopping the use of our drug. Probably, it would be difficult to find a more eloquent confirmation for the excellent quality of BCD-055.”

The analysis of efficacy, safety and immunogenicity showed that there were no significant differences between BCD-055 and the original drug. The analysis of safety demonstrated that both drugs had similar characteristics of tolerance, as there were no differences by any of the assessed safety parameters and no cases of unforeseen toxicity.

The biosimilar will be available for sale as early as this year. According to preliminary estimates, the Russian-made product will reduce the cost of treatment by more than 50% compared to the price of original drug reported prior to the release of biosimilars.