• Walter Reinisch and Josef Smolen.
• Department of Medicine, McMaster University, Hamilton, Ontario, Canada; Department of Internal Medicine III, Division of Gastroenterology and Hepatology, Medical University Vienna, Wien, Austria. Electronic address: reinisw@mcmaster.ca.
• Semin. Arthritis Rheum. 2015 Jun 1; 44 (6 Suppl): S9-15.

ObjectivesThis article provides insight into the guidelines issued by the European Medicines Agency (EMA) and the draft guidances issued by the US Food and Drug Administration (FDA) regarding potential safety considerations associated with the development and use of biosimilars.MethodsEMA and FDA guidelines and the literature were reviewed to identify recommendations and experience of manufacturers regarding the safety of biosimilars.ResultsRecent results of phase 3 comparability clinical trials comparing biosimilars with their reference products, and the approval of a biosimilar infliximab by several regulatory agencies, demonstrate the growing importance of biosimilars in inflammatory diseases. The safety profiles of biosimilars developed according to regulatory guidelines appear to be highly similar to the reference product, and postmarketing pharmacovigilance programs are in place. Additional topics related to biosimilars, such as interchangeability, automatic substitution, and nomenclature, are discussed.ConclusionsSafety considerations in the development of biosimilars are an important focus of regulatory guidelines, although topics such as interchangeability, automatic substitution, and nomenclature are still being debated.Copyright © 2015 The Authors. Published by Elsevier Inc. All rights reserved.

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