Opinion
Published on 12 January 2026
Biosimilars: still safe, still effective, still not generics. Why is FDA suddenly pretending they are?
Author(s): Michael S Reilly, Esq, Professor Philip J Schneider, MS, FASHP, FASPEN, FFIP, Andrew Spiegel, Esq
biosimilars, FDA guidelines, genericization of biosimilars, interchangeable biosimilar, pharmacy substitution, totality of evidence
DOI: 10.5639/gabij.2026.1501.
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