How Prepared Is the United States for the Transition of Insulins to Regulation as Biologics?

While drug makers who sell insulin in the United States have had the past decade to prepare for the transition, stakeholders within the diabetes community must grapple with the potential impacts that this regulatory change could have.
Kelly Davio
August 20, 2019
Within the Biologics Price Competition and Innovation Act, passed as part of the Affordable Care Act, is a provision at 7002(e) that stipulates that some products previously regulated under the Food, Drug and Cosmetic (FD&C) Act would be allowed a 10-year transition period before they would be deemed to be licensed under the Public Health Service (PHS) Act. That transition period will expire on March 23, 2020; at that time, approved applications for biologics—including insulin products—that were originally approved under the FD&C Act will be treated as though they were licensed under the PHS Act.

While drug makers who sell insulin in the United States have had the past decade to prepare for this transition, stakeholders within the diabetes community must grapple with the potential impacts that this regulatory change could have. This month, a current opinion published in BioDrugs laid out the key considerations related to the transition.

First, it is important to note that insulins have always been biologics from a scientific perspective, and the products themselves will not change as a result of bringing them under regulation as biologics as a matter of law.

However, labeling for these products will change, and patients and their healthcare providers must be made aware of this fact. According to that authors, while the FDA has indicated that labeling changes will be minimal in nature, questions remain as to whether the same insulin product could be allowed on the market with 2 different labels at the same time as products make their way through the supply chain. Removing products with older labels from sale would result in considerable wastage of insulin, and that fact could create concerns among patients with respect to supply of this crucial drug.

Additionally, the potential for interchangeable biosimilar insulins will eventually raise questions about substitution at the pharmacy level. However, interchangeability will not be possible immediately given that all insulins will be designated as stand-alone products as of March 2020—none will be deemed biosimilars, even those that were approved as follow-ons (such as the follow-on insulin glargine, Basaglar, which references Lantus).

The authors also point out that the transition could actually delay the availability of interchangeable insulins; in addition to the so-called regulatory “dead zone” for insulin applications, which has been described elsewhere, the authors note that an interchangeable designation can only be pursued for a product already designated biosimilar by the FDA; since no insulins will be biosimilars as of the transition date, no interchangeable designations can be sought for these products until biosimilars are eventually approved.

“Consequently, the rolling over of the current biologics is likely to delay the availability of interchangeable insulin products,” they write.

Given the potential for patient and provider confusion, the authors call on the FDA to educate all impacted stakeholders; “the need to reconcile the information seen by patients on their medicines with that recorded in formal medical records and drug tracing systems is clear,” they write, but it is not yet clear that these needs have been fully evaluated and planned for at the regulatory level, and questions remain as to whether competition and access will be hindered—rather than facilitated—by the regulatory rollover.

George K, Woollett G. Insulins as drugs or biologics in the USA: what difference does it make and why does it matter? [published online August 6, 2019.] BioDrugs. doi: 10.1007/s40259-019-00374-1.


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