Editor’s Choice

Equivalence and regulatory approaches of nonbiological complex drug products across the United States, the European Union, and Turkey

Regulatory agencies around the world apply different standards and approaches to the evaluation and approval of drug products and biological products, and these differences are particularly pronounced in the development of nonbiological complex drug follow-on products. This review compares the approaches of the U.S. Food and Drug Administration, the European Medicines Agency, and the Turkish Medicines and Medical Devices Agency, specifically highlighting the policies and pathways across these agencies in the assessment of the bioequivalence of glatiramer acetate, enoxaparin sodium, and sodium ferric gluconate complex products, and concludes that no well-defined or comparable regulatory evaluation approach yet exists for nonbiological complex drugs and their follow-on products.

NYAS Editor's Choice

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