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In Vitro Methods for Comparing Target Binding and CDC Induction Between Therapeutic Antibodies: Applications in Biosimilarity Analysis
Published on: May 4, 2017
Streamlined approval of biosimilars: moving on from the confirmatory efficacy trial
Marie-Christine Bielsky1, Anne Cook1, Andrea Wallington1
1Medicines & Healthcare Products Regulatory Agency, 10SC Canary Wharf, E14 4PU, London, UK.
Abstract:
Licensing of biosimilars is essential to promote patient access to 21st-century biological medicines. Regulatory approval of biosimilars is based on the totality of evidence from a head-to-head comparison with reference products (RPs). A clinical efficacy trial is usually required, but this is increasingly questioned. Based on a thorough review of biosimilar applications in the European Union (EU), we conclude that in-depth knowledge of the reference product, allied with high-performing analytical tools, largely predicts clinical comparability, subject to confirmation by a comparative pharmacokinetic (PK) trial. We provide a blueprint for a biosimilar pathway that reduces the need for clinical efficacy trials in exceptional cases, together with qualifying criteria and requirements for streamlined assessment to expedite wider access to affordable biological medicines.
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