The biosimilar industry is witnessing unprecedented growth with an increase in newer, complex therapeutics increasing over time. A biosimilar product is expected to exhibit similar safety, efficacy, and quality as that of the approved originator product. The key step towards biosimilar development and approval primarily relies on analytical similarity with respect to the originator, hence choosing appropriate analytical platforms is highly critical in determining the critical quality attributes (CQAs) and batch release criteria of therapeutics to establish a robust analytical similarity exercise. An extensive array of orthogonal analytical tools can fulfill this objective by providing information with regard to primary structure; higher-order structure, product-related impurities, and stability. In the present work, we have established an analytical platform for insulin glargine, the first basal long-acting insulin analogue using mass spectrometric, chromatographic, and spectroscopic techniques. We have examined the structural and functional similarity of insulin glargine biosimilars with respect to its originator product, Lantus® (Sanofi) to monitor the quality of approved therapeutics in the Indian market. The results offer robust evidence of structural and functional similarity across insulin glargine biosimilars to Lantus®. However, Biosimilars 1 and 3 exhibited a higher rate of impurity generation (0.78% and 0.73% per week, respectively), as compared to others (0.02% to 0.43% per week) and Biosimilar 4 exhibited greater content of high molecular weight (HMWs) (0.80%) and related substances (RS) (0.45±0.06%) as compared to others (HMWs of 0.04% and RS of 0.17%) and this impact product stability. Further, %aggregation at 14 days was statistically correlated (R2 = 0.99, RMSE = 0.095) with %aggregation at 0 days (linearly) and the number of months from expiry (non-linearly), highlighting the overpowering impact of the latter. The order of analytical similarity was calculated using Euclidean distance as Lantus®&gt;Biosimilar 2&gt;Biosimilar 4&gt;Biosimilar 1&gt;Biosimilar 3.

Structural and functional similarity assessment of insulin glargine biosimilars

ACS Spring 2022

The official archive and repository for all ACS Meetings & Expositions abstracts and select posters or presentations.