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Biosimilar Hearing Will Consider Whether 'Umbrella' Exclusivity Policy Warranted

 
• By Derrick Gingery

US FDA asks for comments on whether the policy employed for small molecule generics also should apply to biosimilars.

mangled umbrella
• Source: brlnpics123

The US FDA will consider whether innovator biologics exclusivity should receive similar treatment as small molecule drugs as part of efforts to enhance biosimilar development and availability.

Agency officials will accept public comments on many biosimilar-related issues during a Sept. 4 public hearing at FDA's White Oak headquarters, scheduled to be announced in July 25 

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