FDA Adds Chemically Synthesized Products to NDA-BLA Transition List

The FDA has updated its list of NDAs that will shift to being regulated as BLAs on March 23, adding new synthesized proteins to reflect a provision in the federal government’s fiscal 2020 budget bill.

The spending bill provision that is now law amended the definition of “biological product” to include “any chemically synthesized polypeptide[s].”

The three chemically synthesized products — Ferring’s Cushing’s syndrome treatment Acthrel (corticorelin ovine triflutate), Pfizer’s antibiotic Elase-chloromycetin (fibrinolysin and desoxyribonuclease combined [bovine] with chloramphenicol) and Sanofi’s diabetes treatment Adlyxin (lixisenatide) — are now seen as biological products.