Introduction of biosimilar insulins in Europe.

ABSTRACT: Regulatory approval of the first biosimilar insulin in Europe, LY2963016 insulin glargine (Abasaglar^® ), in 2014 expanded the treatment options available to people with diabetes. As biosimilar insulin products come to market, it is important to recognize that insulin products are biologicals manufactured through complex biotechnology processes, and thus biosimilar insulins cannot be considered identical to their reference products. Strict regulatory guidelines adopted by authorities in Europe, the USA and some other countries help to ensure that efficacy and safety profiles of biosimilar insulins are not meaningfully different from those of the reference products, preventing entry of biological compounds not meeting quality standards and potentially affecting people's glycaemic

SUBMITTER: Davies M 

PROVIDER: S-EPMC5637898 | biostudies-literature | 2017 Oct

REPOSITORIES: biostudies-literature