The biosimilars market is yet to fully come to fruition and the race is still on to obtain product approval. The regulatory guidelines recommend the application of state-of-the-art characterization studies to demonstrate that the structural and physico-chemical attributes of a biosimilar are comparable to the reference medicinal product (RMP).

In this publication (European Biopharmaceutical Review July 2017, pages 50-56. © Samedan Ltd), we discuss the higher order structure (HOS) aspects of the current biosimilar guidelines and the ICH Q6B guidelines, including examples of the required analyses, detail regarding which analyses should be performed when and also how the data can assist in defining biosimilarity.

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