USA – FDA Compiles List of NDAs Transitioning to BLAs Next March

The US Food and Drug Administration (FDA) on Tuesday released a preliminary list of the new drug applications (NDAs) that will be converted to biologics license applications (BLAs) on 23 March 2020.

The shift is caused 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).”

According tdraft guidance released last December, FDA interprets the term “protein” to mean “any alpha amino acid polymer with a specific defined sequence that is greater than 40 amino acids in size.” And FDA said it interprets the term “chemically synthesized polypeptide” to mean any alpha amino acid polymer that “(1) is made entirely by chemical synthesis and (2) is greater than 40 amino acids, but less than 100 amino acids in size.”…