Biosimilars are approved following a regulatory pathway different to that of generics, as they are not molecularly identical to their reference products. Currently, only one biosimilar is approved by the European Medicines Agency (EMA) for the treatment of rheumatological diseases: an infliximab biosimilar, which is commercialized as Remsima/Inflectra . With this approval in mind, author Gilberto Castañeda-Hernández and co-authors discuss what rheumatologists should know about biosimilars .
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