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Bioanalytical Methods in Support of Biosimilar Drug Development

Organized by: Biosimilars Focus Group
Moderated by: Shefali Kakar, Novartis
Produced By:

About the Webinar: When developing biosimilar drugs, it is critical to demonstrate biosimilarity to the originator drug including similarities of physical and chemical properties as well as Pharmacokinetic (PK) analyses. Proving the similarities can be challenging and developing PK and immunogenicity assays to demonstrate biosimilarity requires specific steps in method development, validation, and sample analysis.

This webinar will summarize recommendations on the development and validation of PK, anti-drug antibody (ADA), and neutralization antibody assays (NAB) for biosimilar drug development as well as review the implications of the recent FDA guidance for industry, Clinical Pharmacology Data to Support a Demonstration of Biosimilarity to a Reference Product .

Learning Objectives:
  • Review the requirements for PK analysis when developing a biosimilar drug.
  • Discuss immunogenicity assay requirements including both screening assays and characterization assays (such as NAB).
  • Explore why spending the time up-front to develop the right assays will save you significant time and expense by ensuring the clinical trial data can be interpreted correctly.
  • Analyze the important points to keep in mind during method development, validation, and sample analysis.

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