Biosimilar and Follow-on Insulin: The Ins, Outs, and Interchangeability.

ABSTRACT: Objective: To provide an overview of the differences between biosimilars and generics, and to summarize regulatory requirements and outstanding issues related to biosimilar insulins in the United States, including the issue of interchangeability. Data Sources: References were obtained using MEDLINE searches, the bibliographies of articles identified during the searches, review articles, and general Internet searches. Key words included the following: diabetes, insulin, biosimilar, regulatory, follow-on, and interchangeability. Study Selection and Data Extraction: Articles, studies, regulatory documents, and opinion pieces that addressed issues around biosimilar/follow-on insulins and interchangeability of insulins in people with diabetes were selected for inclusion in

SUBMITTER: White J 

PROVIDER: S-EPMC6313268 | biostudies-literature | 2019 Feb

REPOSITORIES: biostudies-literature