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Countdown To Transition: US FDA Says 91 Drugs Will Become Biologics In March 2020

 
• By Sue Sutter

A Pink Sheet infographic shows how insulins account for the largest category of transition products, with 27 NDAs that will be "deemed" BLAs in six months; agency is working on a policy to address the transition of authorized generic insulins to regulation under the PHS Act, Office of Therapeutic Biologics And Biosimilars acting policy director Eva Temkin says.

Magician hand with magic wand - Image
With the wave of a magic wand, 91 NDAs will become BLAs on 23 March 2020. • Source: Shutterstock

With just six months to go before dozens of protein products originally approved as drugs magically turn into biologics, the US Food and Drug Administration is providing more clarity on the identity of the affected applications.

On 24 September, the agency issued an updated, preliminary list of 91 new drug applications approved under the Food,...

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EMA Backs Gilead’s Yeytuo And 13 Other Drugs For EU Approval But Rejects Three

 
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