After decades of experience, there is not much data to show that comparative efficacy trials yield information that indicates a clinically meaningful difference between a biosimilar and the reference product. There is increased confidence in comparative analytical data, and it is accepted that clinical endpoints are not as sensitive as analytical data to detect any differences.

Join us as our panelists discuss how to rely less on clinical trials in the development of biosimilars, and the benefits this affords, such as:

• Time and cost savings for R&D, manufacturing, and production
• Increased pace for patient access to biosimilars
• Reduction of unnecessary testing and redundancy
• Elimination of arbitrary clinical judgments
• Potential changes in the regulatory approval requirements for biosimilars