Toggle Main Menu Toggle Search

Open Access padlockePrints

Understanding Biosimilar Insulins - Development, Manufacturing, and Clinical Trials

Lookup NU author(s): Emeritus Professor Philip Home


Full text for this publication is not currently held within this repository. Alternative links are provided below where available.


© 2022 Diabetes Technology Society.Background: A wave of expiring patents for first-generation insulin analogues has created opportunities in the global insulin market for highly similar versions of these products, biosimilar insulins. Biologics are generally large, complex molecules produced through biotechnology in a living system, such as a microorganism, plant cell, or animal cell. Since manufacturing processes of biologics vary, biosimilars cannot be exact copies of their reference product but must exhibit a high degree of functional and structural similarity. Biosimilarity is proven by analytical approaches in comparative assessments, preclinical cell-based and animal studies, as well as clinical studies in humans facilitating the accumulation of evidence across all assessments. The approval of biosimilars follows detailed regulatory pathways derived from those of their reference products and established by agencies such as the European Medicines Agency and the US Food and Drug Administration. Regulatory authorities impose requirements to ensure that biosimilars meet high standards of quality, safety, and efficacy and are highly similar to their reference product. Purpose: This review aims to aid clinical understanding of the high standards of development, manufacturing, and regulation of biosimilar insulins. Methods: Recent relevant studies indexed by PubMed and regulatory documents were included. Conclusions: Driven by price competition, the emergence of biosimilar insulins may help expand global access to current insulin analogues. To maximize the impact of the advantage for falling retail costs of biosimilar insulins compared with that of reference insulins, healthcare professionals and insulin users must gain further awareness and confidence.

Publication metadata

Author(s): Heinemann L, Davies M, Home P, Forst T, Vilsboll T, Schnell O

Publication type: Review

Publication status: Published

Journal: Journal of Diabetes Science and Technology

Year: 2022

Pages: epub ahead of print

Online publication date: 11/07/2022

Acceptance date: 02/04/2018

ISSN (print): 1932-2968

ISSN (electronic): 1932-2968

Publisher: SAGE Publications Inc.


DOI: 10.1177/19322968221105864

PubMed id: 35818669