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Biosimilars – Increasing Regulatory Focus on Orthogonal Analytical Characterisation

The COVID-19 pandemic has focused attention upon global pharmaceutical industries, and will continue to do so for some time to come. However, despite the initial disruption, some positive outcomes may be emerging from 2020 for the future of biotherapeutics in 2021 and beyond. One area which may be becoming more transparent is in the biosimilar regulatory sphere. Fiona Greer, Independent Consultant and Richard Easton at BioPharmaSpec look at proposed changes of regulatory emphasis from a global perspective and consider any potential impact on our analytical strategies for biosimilar testing.