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Considerations in biosimilar insulin device development

Authors Fry A, Krentz A, Hompesch M

Received 8 October 2015

Accepted for publication 28 October 2015

Published 16 February 2016 Volume 2016:6 Pages 9—15


Checked for plagiarism Yes

Review by Single-blind

Peer reviewers approved by Dr Amy Belton

Peer reviewer comments 2

Editor who approved publication: Professor Shein-Chung Chow

Andy R Fry,1 Andrew J Krentz,2 Marcus Hompesch2

1Team Consulting Limited, Ickleton, Cambridge, UK; 2Profil Institute for Clinical Research, Chula Vista, CA, USA

Abstract: Biosimilar insulins, also known as follow-on biologics, are modifications of an originator insulin that are intended to be clinically equivalent to the licensed product. For injectable insulins, or other peptides used in the management of diabetes, regular use of an insulin pen injector or other device to administer therapy is part of the patient's self-management regimen. By definition, the biosimilar product should have comparable pharmacokinetic and pharmacodynamic properties to the reference product. However, the device is the initial interaction for the patient rather than the product contained within. We consider the regulatory aspects of insulin device development. The options for manufacturers bringing a biosimilar insulin to market, including whether to outsource development of delivery devices, are explored. The structure of a device development program is outlined and issues of accuracy, safety, ease of use, and attractiveness of modern insulin delivery devices are discussed.

Keywords: biosimilar insulin, delivery devices, diabetes mellitus

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