Expert Opinion on Biological Therapy (09/15) P. 1; Schellekens, H.; Lietzan, E.; Faccin, F.

One important way of simplifying biosimilar development is extrapolation of safety and efficacy data. Regulatory authorities generally agree that extrapolation of similarity from one indication to other approved indications of the reference product should be allowed if scientifically justified. For instance, the biosimilar infliximab (Remsima, Inflectra) to the innovator monoclonal antibody infliximab (Remicade) was recently approved in the European Union, Canada, and South Korea. Taking into consideration two clinical trials of biosimilar infliximab in patients with rheumatoid arthritis and ankylosing spondylitis, the European Medicines Agency allowed extrapolation to all eight approved indications for innovator infliximab. Health Canada, however, did not permit extrapolation to the indications for ulcerative colitis and Crohn's disease. The researchers propose key scientific considerations for indication extrapolation and assert that "the preclinical and clinical criteria that are currently required to merit indication extrapolation have not been rigorously evaluated."

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