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Indication extrapolation for anti-TNF biosimilars

Biosimilar monoclonal antibodies (mAbs) to TNF are being developed that are highly similar, but not identical to the innovator molecules. CT-P13, a biosimilar of infliximab, is the first anti-TNF mAb to get approval in South Korea, Europe and Canada. However, uncertainties remain about indication extrapolation and interchangeability.

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Figure 1: Putative mechanisms of action of anti-TNF mAbs.


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Correspondence to William J. Sandborn.

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Competing interests

N.V.C. is a Postdoctoral Fellow of the Research Foundation-Flanders (FWO), Belgium, received consultancy fees from Janssen Biologics BV, MSD, Pfizer and UCB, and speaker's fees from Abbvie. W.J.S. received research support and consultancy fees from Abbvie, Amgen, Janssen and Pfizer, and consultancy fees from UCB.

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Vande Casteele, N., Sandborn, W. Indication extrapolation for anti-TNF biosimilars. Nat Rev Gastroenterol Hepatol 12, 373–374 (2015).

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