HCP Live June 6, 2024
The Council recommends the elimination of unnecessary clinical efficacy trials and establishing global regulatory comparators.
The Biosimilars Council published a new position paper outlining their suggestions regarding streamlining regulatory requirements for biosimilar development.1 These changes aim to enhance access, affordability, and efficiency in bringing these critical treatments to market faster.
Currently, the US Food and Drug Administration (FDA) requires that a biosimilar application must include data demonstrating high similarity between the biosimilar and reference drug, a toxicity assessment, and ≥ 1 clinical study that proves the potency, purity, and safety of the biosimilar, unless otherwise stated by the FDA. They also usually require a comparative pharmacokinetic (PK) data—and sometimes comparative pharmacodynamic (PD) clinical data—as well as an immunogenicity assessment and...
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