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