Comparative effectiveness and safety of insulin reference biologics versus biosimilars for types 1 and 2 diabetes mellitus: Protocol for a systematic review of real-world studies.

ABSTRACT:

Introduction

Diabetes mellitus is characterized by insulin deficiency or resistance. The two main types of diabetes mellitus are type 1 (T1DM) and type 2 (T2DM). Insulin is the mainstay of therapy for T1DM and often the last-line therapy for T2DM. Biosimilar insulins are cost-saving alternatives to reference products that may improve access for patients and sustainability for healthcare systems. Despite supporting evidence from randomized controlled trials, biosimilar insulin uptake is poor, and real-world evidence of their safety and effectiveness is limited.

Objective

Our objective is to compare the real-world effectiveness and safety of insulin biosimilars versus reference products in adults with diabetes mellitus.

Eligibility criteria

We will include observational

SUBMITTER: Ho MKH 

PROVIDER: S-EPMC12310029 | biostudies-literature | 2025

REPOSITORIES: biostudies-literature