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Use of Maurice CE-SDS in ICH Q6B Based Biosimilar Comparability Exercises

by Lyndon Gledhill, Michael-John O’Connor, Dr. Richard L. Easton.. BioPharmaSpec Ltd, Jersey, JE2 7LA, UK

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The biosimilars market is a hugely significant sector of the biopharmaceutical industry with long-term, significant growth projections. The main attraction for manufacturers to produce biosimilars is the decreased time to market, owing to a more abbreviated pathway to regulatory approval. The route to market places strong emphasis on the analytical and characterization techniques used to investigate the structure of the molecule and, most importantly, side-by-side comparability exercises between the biosimilar and innovator products.

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