Perceptions and realities of clinical safety of biosimilars – EU and US perspectives: Part 1

Perceptions and realities of clinical safety of biosimilars – EU and US perspectives: Part 1

This article is Part 1 of a two-part paper appraising the clinical safety of known EU-approved biosimilar therapeutic protein medicines pre-approval and post-approval, and compares and contrasts with the long awaited overarching FDA biosimilars guidances, “nally issued in February 2012. The paper aims to provide assurance of the safety of as yet unapproved potential biosimilars including the recombinant monoclonal antibodies (mAbs), insulins, heparins, and interferons. Biosimilar medicinal development, perception of general risk, interchangeability, substitution and other implications during acute or chronic use, “rst/second line, or adjunct therapy, are addressed here. Part 2 will be published in next month’s issue.

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