Efficacy and immunogenicity of insulin biosimilar compared to their reference products: a systematic review and meta-analysis.

ABSTRACT:

Background

To ascertain the efficacy, safety, and immunogenicity from existing evidence via conducting a meta-analysis of randomized controlled trials between biosimilar and originator insulins.

Methods

The PubMed, Cochrane Library, EMBASE, and ClinicalTrails.gov were searched to identify head-to-head randomized controlled trials (RCTs) that directly compare the efficacy and safety of biosimilar insulin and its originator. Efficacy was assessed by change of HbA1C, fasting plasma glucose (laboratory or self-monitoring of blood glucose (SMBG)), and change all mean of 7 points- or 8 points- SMBG. Safety was assessed by change in proportion hypoglycemia and serious hypoglycemia. The occurrence of anti-insulin antibodies (AIAs) was also evaluated.

Results

Fourteen RCTs wit

SUBMITTER: Yang LJ 

PROVIDER: S-EPMC8817566 | biostudies-literature | 2022 Feb

REPOSITORIES: biostudies-literature