Gov­ern­ment spend­ing bill tweak means 3 more NDAs will be­come BLAs, FDA says

As some in­sulin, hu­man growth hor­mone and oth­er prod­ucts tran­si­tion on 23 March from new drug ap­pli­ca­tions (NDAs) to bi­o­log­ics li­cense ap­pli­ca­tions (BLAs), the re­cent­ly passed gov­ern­ment spend­ing bill in­clud­ed a fur­ther tweak to add new pro­teins to the tran­si­tion.

The NDA to BLA change ef­fec­tive­ly means that any fol­low-on prod­ucts for these NDAs will need to win ap­proval as biosim­i­lars af­ter March. The tran­si­tion was cre­at­ed by the Bi­o­log­ics Price Com­pe­ti­tion and In­no­va­tion Act of 2009, which clar­i­fied the statu­to­ry au­thor­i­ty un­der which cer­tain pro­tein prod­ucts will be reg­u­lat­ed by amend­ing the de­f­i­n­i­tion of a “bi­o­log­i­cal prod­uct” to in­clude a “pro­tein (ex­cept any chem­i­cal­ly syn­the­sized polypep­tide).”

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