Webinar Recording

AAPS Webinar: Bioanalytical Methods in Support of Biosimilar Drug Development


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.

This webinar will summarize the recommendations from the AAPS Ligand Binding Assay Biosimilar subcommittee and Biosimilars Action Program Committee on the Development and Validation of PK, Anti-Drug Antibody (ADA), and Neutralization Antibody Assays (NAB) for Biosimilar Drug Development and will describe how this information can be used to reduce the risks present in biosimilar drug development.

We will also discuss the recently released FDA guidance, “Clinical Pharmacology Data to Support a Demonstration of Biosimilarity to a Reference Product”, and its implications for clinical pharmacology studies for proposed biosimilar products.


  • 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.
  • Review recommendations in recently released FDA guidance on how clinical pharmacology studies should be designed in support of biosimilar product applications.


This webinar is now available for on-demand viewing. Watch the recording for a limited time!

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    Dominique Gouty, Ph.D.

    Senior Vice President of Business Operations

    Dr. Dominique Gouty has over 20 years of industry experience spanning R&D, clinical operation, and manufacturing, and is a leading expert in key subjects concerning preclinical and clinical bioanalysis for novel therapeutic biologics and biosimilars.

    PD Dr. Arno Kromminga

    Senior Vice President and European CSO

    Dr. Arno Kromminga is a certified specialized immunologist with 20+ years expertise covering the entire cascade of assay strategy and characterization of immune responses against biological therapeutics. A pioneer in the area of immunogenicity, his laboratory brought the first biosimilar EPO to approval in Europe and supported the first biosimilar EPO submission in the U.S.