BIOСAD has successfully completed the main stage of clinical trials for the Russian biosimilar of adalimumab, a drug intended for the treatment of various autoimmune and chronic inflammatory diseases in adults and children, including the rheumatoid arthritis and severe psoriasis vulgaris.
In the past 6 years, BIOCAD, a biotech company, was actively developing BCD-057, a genetically engineered drug, which is the Russian biosimilar of adalimumab and allows to cut down by 30 to 50% the costs of the treatment for patients with rheumatic diseases and psoriasis. The biosimilar was developed in full compliance not only with the Russian laws, but also with the main international recommendations for the studies in the area of biosimilar monoclonal antibodies, and required more than 900 million rubles of investments.
The trials fully confirmed the equivalence of the Russian biosimilar with adalimumab, the foreign original drug – by week 16 of the treatment, PASI 75 was achieved in 62.5% of patients in the group treated with BCD-057; and, in the group treated with the original drug, this figure was 66.5%. The absence of differences compared to the original drug was also demonstrated for other characteristics of the disease (sPGA, BSA, itch, HRQL); both drugs have equivalent safety profile.
The successfully completed main stage of phase 3 registration clinical trials is the last step in the development of medicinal product before its registration and market launch. It is expected that its cost will be at least a quarter lower than the one of the original drug.