Why Biosimilars can Never be Identical to Originators-and Why they Don't Need to be
Reinke, T.
Managed Care 28(1): 10-11
2019
ISSN/ISBN: 1062-3388 PMID: 30883316 Document Number: 697794
The FDA's approval criteria require a biosimilar to be highly similar to its original biologic and show "no clinically meaningful differences." But mere similarity is not close enough for many clinicians and some patients; it makes biosimilars seem riskier than the original biologics.
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