Monoclonal Antibody Biosimilars

The first mAb biosimilars to be approved in Europe and elsewhere was the infliximab biosimilars (Inflectra and Remsima), which originator is Remicade. In October 2013, after the European Medicines Agency (EMA) gave a positive opinion for infliximab biosimilars, the European Commission granted a marketing authorization (MA) for these two biosimilars in the various therapeutic indications that are authorized for Remicade (i.e. indications in gastroenterology, rheumatology, and dermatology). As for previously approved biosimilars, the two aforementioned European institutions did not make a stand on the issues of substitution, and with good reason, as answering these questions does not fall within their areas of expertise and is the sole responsibility of EU Member States