Efficacy and safety of biosimilar insulins compared to their reference products: A systematic review.

ABSTRACT:

Importance

For nearly a century, no generic form of insulin has been available in the United States. However, the first biosimilar insulin, Basaglar, was approved by the U.S. Food and Drug Administration in 2015, and subsequently Admelog and Lusduna in 2017.

Objective

To summarize the scientific evidence comparing the safety, efficacy, pharmacokinetics, and pharmacodynamics of biosimilar and reference insulin products.

Data sources

We conducted a systematic review using PubMed, Cochrane, Embase, Latin America and Caribbean Health Sciences, South Asian Database of Controlled Clinical Trials, and IndiaMED from their inception through January 14, 2018.

Study selection

We included randomized controlled trials (RCTs) comparing safety, clinical efficacy, pharmacokine

SUBMITTER: Tieu C 

PROVIDER: S-EPMC5905882 | biostudies-literature | 2018

REPOSITORIES: biostudies-literature