Last week, the FDA compiled a preliminary list of NDAs that will be converted to BLAs in view of the new interpretation of the terms “protein” and “biological product” in the FDA’s “Deemed To Be A License” draft guidance, which was released in December 2018. In the draft guidance, the FDA interpreted the term “protein” to mean “any alpha amino acid polymer with a specific defined sequence that is greater than 40 amino acids in size.” Under the BPCIA, the definition of the term “biological product” was amended to include a “protein (except any chemically synthesized polypeptide),” where the 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.”
These changes mean that any follow-on products for the applications that were converted from NDAs to BLAs will be considered biosimilars during their approval process. The FDA noted that this preliminary list, designed to “enhance transparency and facilitate planning for the March 23, 2020, transition date,” and effective as of August 31, will be periodically updated before the transition date next spring.