Journal of Internal Medicine (09/15) Isaacs, J.D.; Cutolo, M.; Keystone, E.C.

Targeted biological therapies have brought significant improvements for many patients with immune-mediated inflammatory diseases (IMIDs) such as rheumatoid arthritis and psoriasis. However, because biological drug development and manufacturing are complex, costs for these therapies can be high. Biological therapies can place a heavy financial burden on healthcare systems, and many patients lack access to effective treatments due to cost issues. With many patents on reference biological therapies have expired or are about to expire, several biosimilars have been developed, and some are already in use in various countries. One example is CT-P13, a biosimilar of the anti-tumour necrosis factor monoclonal antibody infliximab, which has received approval in Europe for the treatment of various IMIDs. An international team of researchers notes that although these biosimilars may be cost-effective, there are other issues to be discussed, including the definition of biosimilarity, the validity of indication extrapolation, interchangeability, and relative immunogenicity of biosimilars and their reference drugs.

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