Current Opinion in Gastroenterology (07/01/2015) Vol. 31, No. 4, P. 290; Gomollón, F.

The European Medicines Agency's recent approval of CT-P13 (Remsima, Inflectra), a biosimilar of the reference infliximab (Remicade), has been widely discussed in areas such as inflammatory bowel disease (IBD) and rheumatology. Biosimilars can reduce the prices of costly biologics for IBD. The guidelines for evaluating biosimilars are different from those of the reference biologics, with regulatory agencies depending on detailed in-vitro studies for defining “high similarity,” and requiring fewer clinical data. Controversy remains in the “extrapolation” of indications, accepted by some agencies but not others. New data are needed to settle this controversy, but only market behavior will show whether biosimilars fuel competition and extend access to biologics while reducing drug costs.

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