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    Similarity Approach for Complex Drugs: Biologics and Non-Biological Complex Drugs

    This article examines regulatory issues related to approvals of biosimilars and Non-Biological Complex Drugs (NBCDs) by both the European Medicines Agency and the US Food and Drug Administration with a focus on issues regarding similarity and bioequivalence. The authors suggest regulatory professionals should be aware of the new challenges for regulatory systems regarding these products as well as the clinical practice implications for substitution and interchangeability. ...