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Gastroenterologists unlikely to use infliximab biosimilar Posted 18/10/2013

Gastroenterologists are unlikely to prescribe an infliximab biosimilar in their Crohn’s disease or ulcerative colitis patients if it has not been clinically tested in inflammatory bowel diseases, according to a report from a research and advisory firm.

More than 90 gastroenterologists and 90 rheumatologists in the US and Europe were surveyed. The results showed that over 70% of surveyed gastroenterologists would not use biosimilar infliximab in Crohn’s disease or ulcerative colitis patients if the clinical trial had only been conducted in rheumatoid arthritis patients, with only a minority of respondents saying that extrapolation of indications for biosimilars is a good idea.

Rheumatologists were also found to be similarly cautious about extrapolation of indications for biosimilars, but most biosimilars of tumour necrosis factor (TNF)-alpha inhibitors under development are being studied in rheumatoid arthritis patients, thus alleviating any such fears. Despite this fact, rheumatologists would prefer longer treatment duration and more patients to be included in clinical trials for biosimilars.

The main rationale for the use of extrapolation is ethical, i.e. so as not to carry out unnecessary human trials. But extrapolation also enables drugmakers to carry out fewer clinical trials thus reducing drug costs and time to get to market, which is important in the development of biosimilars.

The European Medicines Agency (EMA) has stated that for extrapolation of data to be considered similarity with the reference product must be convincingly demonstrated. Then, if clinical similarity can be shown in a key indication, extrapolation of efficacy and safety data to other indication(s) of the reference product may be possible, but only if the safety profile of the biosimilar has been properly characterized and unacceptable immunogenicity excluded. Thus, extrapolation of data to other indications of the reference biological, and formal lack of a clinical trial in the respective clinical indication, do not imply less reassurance as regards efficacy and safety of the biosimilar [1].

This report, however, highlights physicians’ concerns over the subject of extrapolation and the need for more information over the safety of biosimilars to be given to physicians to ensure continued access to affordable medicines.

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Reference

1. GaBI Online - Generics and Biosimilars Initiative. Efficacy, extrapolation and interchangeability of biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2013 Oct 18]. Available from: www.gabionline.net/Biosimilars/Research/Efficacy-extrapolation-and-interchangeability-of-biosimilars

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Source: BioPortfolio

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