On December 12, 2018, FDA issued a proposed rule to amend the definition of “biological product” to conform to the definition provided by BPCIA. The proposed rule would also provide FDA’s interpretation of the statutory terms “protein” and “chemically unsynthesized polypeptide.” If finalized, the rule would take effect on the earlier of 60 days after publication in the Federal Register or March 23, 2020.

The proposed rule defines “biological product” as “a virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, protein (except any chemically synthesized polypeptide), or analogous product, or arsphenamine or derivative of arsphenamine (or any other trivalent organic arsenic compound), applicable to the prevention, treatment, or cure of a disease or condition of human beings.” This is consistent with BPCIA’s definition that includes proteins in the definition of biological products.

Additionally, the proposed rule adds a definition for “protein” as “any alpha amino acid polymer with a specific, defined sequence that is greater than 40 amino acids in size.” It also adds a definition for “chemically synthesized polypeptide” as “any amino acid polymer that is made entirely by chemical synthesis and is greater than 40 amino acids but less than 100 amino acids in size.” The proposed rule indicates that for purposes of these two definitions, “[w]hen two or more amino acid chains in an amino acid polymer are associated with each other in a manner that occurs in nature, the size of the amino acid polymer…will be based on the total number of amino acids in those chains, and will not be limited to the number of amino acids in a contiguous sequence.”

Readers are encouraged to read the proposed rule, also available on Federal Register’s website.