20.02.2018 Media release

Russian infliximab biosimilar has been proved equivalent to Remicade® in international clinical trials

In January 2018, BIOCAD's infliximab biosimilar was approved in Russia. The approval was based on comprehensive preclinical and clinical data that proved the biosimilarity of infliximab biosimilar and Remicade®. 

Rheumatoid arthritis and ankylosing spondylitis affect about 2% of the population worldwide. Infliximab is the active ingredient of the Johnson&Johnson's original drug Remicade®, whichwas one of the top 50 best-selling drugs by global sales in 2016. Infliximab is an inhibitor of the tumor necrosis factor alpha and is typically used as first-line therapy for many immune-mediated inflammatory diseases. In different countries, the cost of the original medicinal product varies from 400 USD to 1500 USD per 100 mg.

Infliximab biosimilar can decrease the treatment cost for rheumatoid arthritis, ankylosing spondylitis, bowel inflammatory disease, and other severe autoimmune disorders. Current competitors to Remicade are infliximab biosimilars by Celltrion and Samsung. The total global sales for infliximab (originator and biosimilars) in 2017 were 8 billion USD, with Remicade's share ofabout 78% (6.3 billion USD).

BIOCAD has now completed the international clinical studies of infliximab biosimilar in ankylosing spondylitis and has finished the main phase of the international clinical study in rheumatoid arthritis. All studies were conducted in direct comparison with Remicade®. The therapeutic effects of the BIOCAD's infliximab biosimilar have been shown equivalent to the effectsof the originator, and the safety profiles of two drugs were similar even in the long-term. BIOCAD ran its clinical studies of the infliximab biosimilar in compliance with the most recent international guidelines including the EMA's guidelines on non-clinical and clinical investigation of similar biological medicinal products containing monoclonal antibodies. 

Initial estimates suggest that the Russian infliximab biosimilar will enter the global market towards the end of 2018 orin early 2019. India, where the market for infliximab amounted to 42 million USD in 2017, is expected to be the first country to receive shipments. Market analysts predict that in 2018, the Indian market for infliximab may grow to 50 million USD.
Infliximab is the fourth monoclonal antibody biosimilar for which BIOCAD gained a regulatory approval. In 2016–2017, BIOCAD began exporting its bevacizumab, trastuzumab, and rituximab biosimilars to international markets, significantly reducing the cost of cancer treatment for patients in Southeast Asia, North Africa, and Latin America.

Recently, the demand for BIOCAD’s products has significantly increased in Vietnam, Sri Lanka, and Morocco. In the near future, BIOCAD will export its products to India, Cuba, and Egypt. BIOCAD already cooperates with partners from over 50 countries in Europe, Asia, Latin America, North and South Africa. The Company is planning to increase the share of its export contracts to 50% from the total contract amount within the next 5 to 6 years.