Biosimilars: A comparability study
Introduction
As blockbuster biologics near patent expiry, the development of biosimilar products is on the rise. This is reflected in the global biosimilar market, which is predicted to increase at a compound annual growth rate of 17.8% between 2023 and 2028, rising from $29.4 billion to $66.9 billion1.
As biologics are inherently complex and rely on living organisms for their production, biosimilar products must undergo rigorous testing to ensure that there are no clinically meaningful differences from the original biologic2.
Why did the customer approach Enzene?
A customer approached Enzene Biosciences to complete comparability testing, focusing on the comparison of the physiochemical and biological properties of a biosimilar monoclonal antibody (mAb) drug product to the reference medicinal product (RMP).
Enzene’s approach
A series of analytical tests — characterizing primary and higher order structure, purity, post-translational modifications, and biological activity — was used to evaluate the comparability of the mAb biosimilar and RMP properties.
The analysis included a comparison of data from an inhibition assay using RAW264.7 cells to measure relative potency, a binding enzyme-linked immunosorbent assay (ELISA), binding affinity of mAb batches to fragment crystallizable receptor (FcRn), and C1q binding potency of mAb batches. All of the analytical tests performed exhibited no significant difference from the RMP.
Outcomes
Therefore, having completed extensive analysis, no meaningful physico-chemical differences between the mAb and RMP meant it could be commercialized as a biosimilar product, helping to drive cost-efficiency in the pharmaceutical industry and broadening access to essential medicines in lower-income countries.
1 Biosimilars Market Size, Share, Trends and Revenue Forecast, accessed 8 February 2024, from: https://www.marketsandmarkets.com/Market-Reports/biosimilars-40.html
2 Biosimilar and Interchangeable Biologics: More Treatment Choices, accessed 8 February, from: https://www.fda.gov/consumers/consumer-updates/biosimilar-and-interchangeable-biologics-more-treatment-choices
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