Perceptions and realities of clinical safety of biosimilars – EU and US perspectives: Part 2
Perceptions and realities of clinical safety of biosimilars – EU and US perspectives: Part 2
This article continues from Part 1 (see Regulatory Rapporteur, April 2012) in appraising the clinical safety of known EU-approved biosimilar therapeutic protein medicines pre-approval and postapproval, comparing current EU regulations with three new FDA biosimilars guidances issued in February 2012: “Scienti#c Considerations”, “Quality Considerations” and “Questions and Answers” (Regulatory). This second article examines the implications of pharmacovigilance and safety attributes being in”uenced by the particular patient population studied. Careful planning of clinical development is highlighted with safety in mind.
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