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Home » FDA prepares for NDA-to-BLA deeming day
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FDA prepares for NDA-to-BLA deeming day

Feb. 20, 2020
By Mari Serebrov
With deeming day a little more than a month away, the FDA is taking final steps to ease the transition of simple proteins approved as new drug applications (NDAs) to biologic license applications (BLAs). The March 23 change will open drugs such as insulin and various hormones to new competition, likely bringing in the next wave of biosimilars. And this time, interchangeability could be riding the crest.
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