Robust bioanalytical methods are essential for successful biosimilar development.

Accurate pharmacokinetic (PK) and immunogenicity assessments require assays that can overcome target- and drug-related interference while delivering reliable analytical performance. This poster highlights the development and qualification of PK and anti-drug antibody (ADA) methods for a biosimilar trastuzumab, demonstrating strategies to optimize assay sensitivity, drug tolerance, and overall assay robustness.

Key highlights include:

• Development and qualification of PK and ADA assays for biosimilar trastuzumab
• Strategies for overcoming target- and drug-related assay interference
• Approaches for improving assay sensitivity and drug tolerance
• Evaluation of assay performance to support reliable PK and immunogenicity assessments
• Practical insights for bioanalytical method development in biosimilar clinical programs

As biosimilar development continues to expand, robust PK and immunogenicity assays are critical for generating reliable clinical data. Learn how optimized assay strategies can support successful biosimilar development and regulatory submissions.