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Equivalence of complex drug products: advances in and challenges for current regulatory frameworks
Author(s) -
Hussaarts Leonie,
Mühlebach Stefan,
Shah Vinod P.,
McNeil Scott,
Borchard Gerrit,
Flühmann Beat,
Weinstein Vera,
Neervannan Sesha,
Griffiths Elwyn,
Jiang Wenlei,
WolffHolz Elena,
Crommelin Daan J.A.,
Vlieger Jon S.B.
Publication year - 2017
Publication title -
annals of the new york academy of sciences
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.712
H-Index - 248
eISSN - 1749-6632
pISSN - 0077-8923
DOI - 10.1111/nyas.13347
Subject(s) - innovator , regulatory science , food and drug administration , white paper , agency (philosophy) , publication , drug , drug development , computer science , business , political science , risk analysis (engineering) , medicine , pharmacology , sociology , intellectual property , law , social science , pathology
Biotechnology and nanotechnology provide a growing number of innovator‐driven complex drug products and their copy versions. Biologics exemplify one category of complex drugs, but there are also nonbiological complex drug products, including many nanomedicines, such as iron–carbohydrate complexes, drug‐carrying liposomes or emulsions, and glatiramoids. In this white paper, which stems from a 1‐day conference at the New York Academy of Sciences, we discuss regulatory frameworks in use worldwide (e.g., the U.S. Food and Drug Administration, the European Medicines Agency, the World Health Organization) to approve these complex drug products and their follow‐on versions. One of the key questions remains how to assess equivalence of these complex products. We identify a number of points for which consensus was found among the stakeholders who were present: scientists from innovator and generic/follow‐on companies, academia, and regulatory bodies from different parts of the world. A number of topics requiring follow‐up were identified: (1) assessment of critical attributes to establish equivalence for follow‐on versions, (2) the need to publish scientific findings in the public domain to further progress in the field, (3) the necessity to develop worldwide consensus regarding nomenclature and labeling of these complex products, and (4) regulatory actions when substandard complex drug products are identified.