FDA Publishes Final Rule for Landmark Shift on Insulins, Other Biological Products


The FDA said it was no longer necessary to include the interpretation of the term “chemically synthesized polypeptide” as first proposed in December 2018.

The FDA Thursday published its final rule about the long-awaited shift that begins March 23, when insulin and certain other biological products transition to a new regulatory pathway, as it amended the definition of “biological product” to match recent statutory changes regarding use of the word “protein.”

In addition, FDA published information for providers and patients about the changes, stressing that the changes won’t have an impact on access, prescribing practices, or product appearance.

Besides insulin, other biological products include human growth hormone (somatropin), pancrelipase, chorionic gonadotropin, follitropin alfa, and menotropins.

The changes reduce “regulatory uncertainty,” the FDA said, and “will allow both FDA and private industry to avoid spending time and resources on case-by-case determinations for each product.”

The final rule, “Definition of the Term ‘Biological Product,’” incorporates changes made by the Biologics Price Competition and Innovation Act (BPCIA) of 2009 and language relating to the FDA in the end-of-year spending bill signed into law by the president in December 2019.

The bill, the Further Consolidated Appropriations (FCA) Act, removed the parenthetical “(except any chemically synthesized polypeptide)” from the category of “protein” in the statutory definition of “biological product.” The parenthetical phrase was included in the BPCIA Act definition of biological product in section 351(i) of the Public Health Service (PHS) Act.

Thus, FDA said Thursday, it was no longer necessary to include the interpretation of the term “chemically synthesized polypeptide” as originally proposed in December 2018.

The definition of “protein” would encompass any alpha amino acid polymer with a specific, defined sequence that is greater than 40 amino acids in size.

Starting March 23, an application for a biological product approved under the Federal Food, Drug, and Cosmetic Act (FD&C Act), including applications for insulins and other biological products, will be deemed to be a license for the product under the PHS Act.

Insulin biosimilars approved under the PHS Act will be able to seek interchangeable designations for the first time, and interchangeable insulins will be, pursuant to state laws, eligible for substitution at the pharmacy level.

“This transition will open new pathways for manufacturers to bring biosimilar and interchangeable versions of insulin and other transitioning products to market, facilitating greater competition in the marketplace,” FDA Commissioner Stephen M. Hahn, MD, said in a statement.

So far, only Boehringer lngelheim Pharmaceuticals has announced its intention to seek interchangeability status, for its adalimumab biosimilar, Cyltezo, which cannot launch until at least July 1, 2023, due to a patent settlement with AbbVie, the manufacturer of the originator product, Humira.

Also on March 23, the FDA will remove biologic products approved through New Drug Applications from the Orange Book and into the Purple Book.

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