Development and validation of pharmacokinetic (PK) and immunogenicity assays supporting demonstration of biosimilarity
For biosimilar drug development, it is critical to demonstrate similar physiochemical characteristics, efficacy, and safety of the biosimilar product compared to the reference product. Pharmacokinetic (PK) and immunogenicity (antidrug antibody, ADA) assays that allow for the demonstration of biosimilarity are critical. Register for this webinar and learn:
- An overview of European Medicines Agency and FDA regulatory guidance on biosimilar drug development
- A review of publications on PK for biologics
- Key issues concerned with development and validation of ligand-binding assays (LBAs) to support the PK assessments and immunogenicity assays for biosimilar drug development
Date: Previously Recorded on June 2nd, 2016
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