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Mylan/Biocon’s Insulin Glargine Would Get A Respite Under US Budget Legislation

 
• By Cathy Kelly

Bill addresses ‘dead zone’ for pending applications for protein products transitioning to biologic status; generic and brand industries each win in different legislative provisions: inclusion of the CREATES Act, and a revised definition for ‘biologics’ that includes chemically synthesized polypeptides.

Syringe

The broad federal budget bill approved by US House and Senate negotiators on 16 December offers relief to sponsors of pending marketing applications for insulin, human growth hormone and other protein agents that are scheduled to transition to biologic status beginning early next year.

The legislation, which must be approved by Congress and the White House by 20 December, would require the Food and Drug Administration to continue to review Sec

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