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FDA Adds Temporary Expertise To ODAC For Filgrastim Biosimilar Meeting

 
• By Derrick Gingery

NIH researcher of cellular therapy manufacturing, experts in pharmacology and pharmaceutical sciences join Oncologic Drugs Advisory Committee for consideration of FDA’s first 351(k) application.

FDA’s first advisory committee for a 351(k) biosimilar application will include a cellular therapy manufacturing researcher along with clinicians and other specialists.

The Oncologic Drugs Advisory Committee is set to meet Jan. 7 to discuss Sandoz Inc.’s filgrastim biosimilar, which has the proposed proprietary name Zarxio

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