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

Regulatory agencies around the world may have different standards and approaches to evaluate and approve drug products and biological products. We describe the U.S. Food and Drug Administration's (FDA) Generic Drug User Fee Act program, as well as their approach to complex products. We discuss...

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Bibliographic Details
Published in:Annals of the New York Academy of Sciences 2017-11, Vol.1407 (1), p.26-38
Main Authors: Oner, Z. Gulsen, Michel, Sarah L.J., Polli, James E.
Format: Article
Language:English
Subjects:
Biological Products - pharmacokinetics
Biological Products - therapeutic use
Copolymer 1
Drug Approval
Drugs
Drugs, Generic - pharmacokinetics
Drugs, Generic - therapeutic use
Equivalence
European Medicines Agency
European Union
follow‐on
Food and Drug Administration
Humans
Medical devices
Medical equipment
nonbiological complex drugs
Policies
Regulatory agencies
Sodium
Therapeutic Equivalency
Turkey
Turkish Medicines and Medical Devices Agency
United States
United States Food and Drug Administration - standards
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Summary:Regulatory agencies around the world may have different standards and approaches to evaluate and approve drug products and biological products. We describe the U.S. Food and Drug Administration's (FDA) Generic Drug User Fee Act program, as well as their approach to complex products. We discuss regulatory approaches for the development of nonbiological complex drug follow‐ons and approval pathways in the United States. We compare FDA policies with other regulatory agencies (i.e., the European Medicines Agency and the Turkish Medicines and Medical Devices Agency). In particular, we describe the policies/pathways across these three agencies to assess equivalence of glatiramer acetate, enoxaparin sodium, and sodium ferric gluconate complex products. We also examine the Turkish market for these selected nonbiological complex drugs.
ISSN:0077-8923
1749-6632
DOI:10.1111/nyas.13505