Abstract:
Biosimilars have been used for 15 years in the European Union (EU). They are able to trigger price competition and reduce costs as well as to increase access to important biological medicines [1]. In spite of the long experience and excellent safety record, many prescribers and other health care professionals have still concerns about the quality, safety, efficacy, and especially interchangeability of biosimilars [2]. Systematic clinical switch studies to demonstrate interchangeability of biosimilars are required in some jurisdictions while theoretical considerations and current clinical data question the feasibility and relevance of such studies.

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This manuscript has been accepted for publication and undergone full peer review but has not been through the copyediting, typesetting, pagination and proofreading process, which may lead to differences between this version and the Version of Record.