Webinar: How to determine the best way to develop and validate pharmacokinetic (PK), immunogenicity (ADA), and neutralizing antibody (Nab) assays for a biosimilar

The US FDA defines a biosimilar as a biological “product highly similar to the reference product without clinically meaningful differences in safety, purity and potency.” In other words, a biosimilar is a copy of an approved version of a biologic drug. There is an increased interest in developing biosimilars for the US and Global markets since many of the first generation biologics’ patents are expiring.

Views about how to approach the development of PK, ADA and NAb assays for biosimilars vary, but what’s the best way? This webinar explores the different options and focuses on the clinical bioanalytical scientific and regulatory aspects of biosimilar drug development. The regulatory aspects, including case studies, is also discussed.

You will learn:

  • Different approaches to the development and validation of PK, ADA, and Nab assays for biosimilars
  • Recent regulatory feedback on the development of bioanalytical assays for biosimilars
  • Key challenges to the bioanalytical support of biosimilar drug development.

Our Expert: George Hristopoulos, Scientific Director, Immunoassay, Intertek Pharmaceutical Services

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