Article: Meeting Regulatory Expectations for Biosimilar Development

Regulatory agencies evaluate biosimilars based on their level of similarity to the reference product. To demonstrate biosimilarity robust analytical characterization studies are required. The biophysical characterisation of biosimilars is important during drug development as biophysical behaviour can impact drug function, activity and stability. Biophysical analytical methods can help to monitor or confirm conformational integrity, the nature of the folded state of the protein and how the peptides associate to form higher order structures. Understanding the interactions between drug substance and excipients, which may potentially alter protein structure and therefore product stability, is important during formulation development, stability studies and comparability.

In this short article, our expert, Anshuman Shukla discusses biophysical characterisation of biosimilars to meet regulatory expectations.

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