Biosimilar Development Recommendations to support informed decision-making earlier in your pipeline
Learning Objectives
- US and EU Regulatory Updates
- Protein Characterization for early stage/pilot batches
- The evolution of drug/target binding affinity and SPR with the Biacore platform
- Considerations for In-vivo support in non-clinical and clinical studies for PK/ADA bioequivalence confirmation
- Recommendations on how to utilize services to guide a more informed decision earlier in your pipeline
Webinar Description
Scientists will share key learnings for biosimilar programs to gain approval in the US and EU. The success of early clinical studies comparing a biosimilar drug candidate with the innovator compound is dependent on the similarity of the products themselves, as well as on the quality of the bioanalytical assay method and the design and conduct of early PK/PD studies.
