Successfully developing a biosimilar begins with a strong analytical strategy.

Early-stage biosimilar development depends on demonstrating analytical and clinical comparability with the reference product. This webinar discusses key scientific and regulatory considerations for biosimilar programs, including analytical characterization, pharmacokinetic (PK) and neutralizing antibody (NAb) assessments, and strategies for supporting successful development in the U.S. and European Union.

Topics include:

• Regulatory considerations for biosimilar development in the U.S. and EU
• Best practices for analytical characterization, PK, and NAb assessments
• The importance of protein characterization during early-stage development
• How surface plasmon resonance (SPR) and the Biacore platform support binding affinity studies
• Strategies for making informed development decisions earlier in the biosimilar pipeline

As biosimilar development continues to expand, robust analytical characterization and well-designed bioanalytical strategies are essential for demonstrating comparability and supporting regulatory success. Discover practical approaches that can help accelerate development while reducing risk throughout your biosimilar program.