Last week, the U.S. Food and Drug Administration (“FDA”) issued a final rule to amend its regulation that defines the term “biological product” in line with the definition set by the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”), as amended by the Further Consolidated Appropriations Act, 2020, enacted on December 20, 2019 (“FCA Act”). 

The BPCIA initially amended the definition of “biological product” in § 351(i) of the Public Health Service Act (“PHS Act”) to include a “protein,” but with a parenthetical carve-out excluding “any chemically synthesized polypeptide.”  The FCA Act later struck this carve-out such that chemically synthesized polypeptides were no longer excluded from the statutory category of “protein.”  The FDA’s final rule makes clear that the agency interprets the term “protein” in line with the latest statutory definition to mean “any alpha amino acid polymer with a specific defined sequence that is greater than 40 amino acids in size,” regardless of whether it is chemically synthesized.

The rule sets the groundwork for the upcoming expiration of the BPCIA’s 10-year transition period on March 23, 2020, after which all therapeutic products meeting the statutory definition of “biological products” will be governed by the PHS Act.  Although the majority of biological products already have been licensed under the PHS Act, some protein products (e.g., insulin and insulin analogs, human growth hormone, pancreatic enzymes, reproductive hormones) historically had been approved under § 505 of the Federal Food, Drug and Cosmetic Act (“FDC Act”). 

The practical effect of the regulation is two-fold.  First, starting on March 23, 2020, insulin products and other biological products approved in the past under § 505 of the FDC Act will now be “deemed” to be licensed and regulated under § 351 of the PHS Act.  Once this transition occurs, sponsors will be able to seek approval of products that are biosimilar to, or interchangeable with, these transitioned products. 

Second, sponsors seeking approval of future biological products that once could have been submitted under § 505 of the FDC Act must now submit a biologics license application under § 351 of the PHS Act.

According to the FDA, the final rule “clarifies the criteria for whether certain products will be regulated as drugs or biological products. The ‘bright-line’ approach under the rule will reduce the amount of time spent by FDA staff and industry in support of making such determinations.”