Seminars in Arthritis & Rheumatism (06/01/2015) Vol. 44, Reinisch, W.; Smolen, J.

The European Medicines Agency and the U.S. Food and Drug Administration have issued guidelines or draft guidelines regarding potential safety considerations associated with the development of biosimilars. Experts reviewed these guidelines and existing literature to identify recommendations and manufacturers' experiences. The safety profiles of biosimilars developed under regulatory guidelines appear to be highly similar to the reference product. Postmarketing pharmacovigilance programs also have been established. Safety considerations in biosimilar development are an important part of regulatory guidelines, but interchangeability, automatic substitution, and nomenclature are still being debated.

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