Nature Reviews Rheumatology (08/18/2015) Dörner, T.; Kay, J.

A recent review looked at biosimilar drugs that have been approved in the last few years to treat rheumatic diseases as well as others that are still in the pipeline. Key challenges posed by biosimilars are also discussed, including the extrapolation of indications to diseases only studied for the reference drug, and the definition of strategies for adequate pharmacovigilance to monitor biosimilars after they receive marketing approval. As an example, the researchers cite CT-P13, the first biosimilar approved for the treatment of inflammatory diseases. They note, however, that some countries did not permit extrapolation of indications for all eight diseases for which the reference drug infliximab is approved. The authors also point out that while drug levels and clinical efficacy may be affected by antidrug antibodies, and "available data suggest that biosimilars and their reference products have comparable immunogenicity, this important property might differ between individual biopharmaceuticals."

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