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European Biopharmaceutical Review

Structural Analytical Challenges in Biosimilar and Generic Drug Development

As the biosimilars market grows, and experiences are drawn from years of product development, the process of getting this class of drugs to market, especially in terms of testing and approval requirements, is being continually examined. Questions are being asked regarding the need for clinical trial analysis, and whether it is more appropriate to front-load biosimilar drug investigations with robust risk-based analyses of the structural properties of innovators compared to biosimilars in comparability exercises. Technological advances in the hardware and software required for structural analysis, such as in mass spectrometry (MS) and techniques for higher order structural investigations, mean that detailed investigations can take place covering all aspects of structure. These can happen at the primary, but also at the secondary and tertiary levels. Investigations of properties of the molecule, which are a function of structure, such as levels of aggregation, are also possible. These detailed investigations, as part of a comparability exercise, can give greater confidence in the nature of the biosimilar, providing information from which risk-based assessments can be made. Furthermore, since the regulatory guidelines invoke ICH Q6B, there is a commonality of analytical expectation and, therefore, subsequent investigation into the same molecular aspects of the biosimilar structure.

Many biosimilars, either on the market today or in the pipeline, have structural features that present particular analytical challenges. However, with the technologies, knowledge, and experience available today, these challenging areas can be teased apart and investigated to give meaningful, comparative data.

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Dr Richard Easton obtained his PhD in glycoprotein structural characterisation using mass spectrometry from Imperial College of Science, Technology and Medicine, UK, and has subsequently spent his career dedicated to the detailed structural analysis of glycoproteins. Richard is Technical Director for Structural Analysis at BioPharmaSpec and is responsible for management of all aspects of carbohydrate and glycoprotein characterisation.

r.easton@biopharmaspec.com
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Dr Richard Easton
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