Considerations in biosimilar insulin device development

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

Acknowledgments

The authors acknowledge the support of the following colleagues in the preparation of this article: Dr Stella Wooder (Team Consulting Ltd), Dr Max Rubin (Cambridge Healthcare Research Ltd), Dr Matteo Perucchini (Cambridge Healthcare Research Ltd), and Mark DiCioccio (Team Consulting Ltd).

Disclosure

The contents of the article and the opinions expressed within are those of the authors. The authors report no conflicts of interest in this work.