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    Optimizing Clinical Trial Data to Support Biosimilars for Market Approval

    This article discusses the differences between biologics and biosimilars and focuses on their molecular dissimilarity. In covering efforts to gain market approval for biosimilars, the author reviews uncertainties associated with biosimilars, the value of pharmacokinetic data as well as therapeutic equivalence trials and their design. The author suggests the time is right for regulators and industry to engage in a critical evaluation of the clinical development of biosimila...