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Impact of biosimilar insulins on clinical practice: Meeting report

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.

Publication metadata

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.


DOI: 10.1177/1932296813518267


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