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

 
• By Sue Sutter

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.

FDA entrance sign 2016

The US FDA has a lot of work to do to encourage both biosimilar competition and innovation in biological product development, if stakeholder comments at a recent public hearing are any indication.

The agency can help spur biosimilar development and market success by finalizing guidance on interchangeability, enhancing public education efforts about...

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