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Lookup NU author(s): Emeritus Professor Philip Home
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The availability of biosimilar insulins can potentially lead to lower insulin costs and increased access for patients with diabetes, worldwide. However, clinicians and regulatory agencies have raised several concerns regarding the safety and efficacy of these new medications. The European regulatory agencies have established guidelines for market approval of biosimilar insulins; however, many issues remain unresolved. Moreover, although the FDA has developed preliminary pathways for biosimilar protein development and is prepared to review each application on a case-by-case basis, insulins do not fall under this pathway at this time. The development of effective postmarketing surveillance protocols, determination of product interchangeability, and product identification/labeling remain key concerns. Numerous issues surround the development and commercialization of biosimilar insulins; thus, it is important that all stakeholders fully understand the complexity of these issues and how they can potentially affect patient care. Bridging the educational gap among clinicians and regulatory agencies will be challenging but necessary for ensuring patient safety. © 2014 Diabetes Technology Society.
Author(s): Dolinar RO, Edelman S, Heinemann L, Home P, Goyal S, Polonsky WH, Schellekens H
Publication type: Article
Publication status: Published
Journal: Journal of Diabetes Science and Technology
Year: 2014
Volume: 8
Issue: 1
Pages: 179-185
Print publication date: 01/01/2014
Online publication date: 01/01/2014
Acceptance date: 01/01/1900
ISSN (print): 1932-3107
ISSN (electronic): 1932-2968
Publisher: Sage Publications, Inc.
URL: https://doi.org/10.1177/1932296813518267
DOI: 10.1177/1932296813518267
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