House Bill Would Keep Insulins From Transitioning to Regulation as Biologics, Biosimilars

When the Biologics Price Competition and Innovation Act was passed as part of the Affordable Care Act (ACA) a decade ago, the United States started a countdown to March 2020, when some drugs—including insulins—that have historically been regulated under the Food, Drug and Cosmetic (FD&C) Act will transition to licensure under the Public Health Service (PHS) Act.

As such, insulins will no longer be treated as drugs but as biologics as a regulatory matter, and subsequent entry insulins will no longer be addressed as follow-on products but will be eligible for authorization under the biosimilar approval pathway. 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.

While regulators, drug makers, and law makers have had the past 10 years to prepare for this regulatory rollover, some legislators have recently expressed concern about the transition and have introduced related bills.

Last month, Representative Mike Kelly, R-Pennsylvania, who is the vice chair of the Diabetes Caucus and a patient with diabetes, introduced H.R.4244, the Market Access for Generic Insulin Competition (MAGIC) Act of 2019. The MAGIC Act would amend the ACA to allow chemically synthesized insulins to be approved under abbreviated new drug applications (ANDAs) under the FD&C Act.

As a result, subsequent-entry insulin products would be generic drugs, not biosimilars.

According to a statement by Kelly, the BPCIA as written “permanently closes the door on generic insulin production after March 2020,” and “The MAGIC Act will ensure that federal law and regulatory barriers at the FDA no longer stand in the way of a competitive market for insulin.”

Kelly’s office notes that the representative contacted FDA Commissioner Ned Sharpless, MD to request information as to why insulin is not eligible for approval via the ANDA process and did not receive a comment from the FDA.

This latest bill comes shortly after another item of legislation, S.2103, was introduced in Congress to address perceived shortcomings of the BPCIA. This Senate bill, the Affordable Insulin Approvals Now Act, would amend the BPCIA to require that insulins with filing dates prior to December 31, 2019, would continue to be reviewed and approved under section 505 of the Food, Drug and Cosmetic Act, even if the review and approval process were to continue past the March transition date for insulins.

These drugs would be deemed to be licensed as biologics effective on either the transition date or the date of approval, whichever comes later.