Biosimilars are rigorously tested to ensure that they meet safety and efficacy requirements established by regulatory agencies including the US Food and Drug Administration (FDA).
Biosimilars follow an established development path. A range of comparative nonclinical and clinical evaluations are completed to ensure that there are no clinically meaningful differences from their reference products1,2:
Data requirements vary on a case-by-case basis; however, extensive manufacturing, non-clinical pharmacology, toxicology, pharmacokinetics, pharmacodynamics, and clinical data must be generated.
Like all pharmaceuticals, biosimilars continue to be monitored and assessed after market introduction.
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