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From Interchangeability To Exclusivity: US FDA Looks For Ways To Make Biologics Market More Competitive

Executive Summary

The agency is being urged to help spur biosimilar development and market success by finalizing guidance on interchangeability, enhancing public education efforts, and taking a more forceful approach to combating misinformation, while reference product sponsors want FDA to adopt 'umbrella' exclusivity to encourage innovative changes in novel biologics.

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