The status of insulins in the US is about to change as a regulatory matter. After March 23, 2020, insulin and other hormone products previously regulated as drugs by the US Food and Drug Administration (even though biologics in science) will become biologics as a regulatory matter and will be licensed under the Public Health Service Act.

In “Insulins as Drugs or Biologics in the USA: What Difference Does it Make and Why Does it Matter?” Avalere experts discuss the following:

• The regulatory history of insulin in the United States
• Changes to the regulatory status of insulins that will take place in spring 2020, as a matter of law
• Ramifications for sponsors, patients, and physicians

They conclude that:

• All stakeholders, especially patients and their healthcare providers, need to understand that the labels of these medicines will change.
• Biosimilar versions of insulins are unlikely to enter the market before 2021, and none of the currently approved insulins will be designated as interchangeable; as such, the policy change is not expected to shift the market outlook in the near term

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