Assessing the Structural and Functional Similarity of Insulin Glargine Biosimilars.

ABSTRACT:

Background

A biosimilar product is expected to exhibit similar safety, efficacy, and quality as that of the approved reference product. Only a few reports of thorough evaluation of the quality of insulin glargine biosimilars are available in literature. Here, we examine the structural and functional similarity of biosimilars of insulin glargine, the first basal long-acting insulin analogue with respect to its innovator product (Lantus^® from Sanofi Aventis).

Methods

Structural similarity was established using mass spectrometry, chromatographic, and spectroscopic techniques. Stability was compared by performing accelerated thermal stress studies. Functional similarity was established via in vitro assay.

Results

Biosimilar 4 exhibited greater content of high m

SUBMITTER: Vishwakarma G 

PROVIDER: S-EPMC10012360 | biostudies-literature | 2023 Mar

REPOSITORIES: biostudies-literature