Today, the U.S. Food and Drug Administration took additional steps to ensure a smooth regulatory transition aimed at increasing patient access to insulin products used daily by millions of Americans to maintain stable blood glucose levels, as well as certain other biological products set to transition regulatory pathways in March. Today’s actions include publishing a final rule and additional resources to provide useful information to stakeholders, including industry, patients and health care providers.

On March 23, 2020, 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 Public Health Service (PHS) Act. This will, for the first time, enable submission of applications for products that are proposed as biosimilar to, or interchangeable with, the transitioned products. As such, the transition of insulin products from approved drug applications to deemed biological product licenses will open up those products to potential biosimilar and interchangeable competition. The availability of approved biosimilar and interchangeable insulin products is expected to increase patient access, adding more choices and potentially reducing costs of insulin products.

“Biologic drugs are often complex therapies that can be used to treat some of the most serious illnesses, including autoimmune diseases, rare genetic disorders and diabetes. Life-sustaining insulin products are biologics, but to date, there has been limited competition in the marketplace, resulting in fewer choices and higher prices for patients. 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,” said FDA Commissioner Stephen M. Hahn, M.D. “These critical therapies often carry a heavy price tag; the cost of insulin has risen over the past decade. Opening these products to increased competition is expected to bring down prices and help patients have access to more choices for these life-saving drugs. We will continue to communicate relevant information, including the resources we’ve issued today, to make the transition from one statutory framework to another as seamless as possible.”

The FDA has taken many steps to date to establish the framework for this new pathway, including issuing the 2018 Biosimilars Action Plan (BAP), which aims to improve the efficiency of the biosimilar and interchangeable product development and approval process and to maximize scientific and regulatory clarity for the biosimilar product development community. The agency has accomplished many of the projects outlined in the Biosimilars Action Plan and is continuing our work on others to enhance patient access to needed medicines in the period leading up to the transition.

Today’s actions, which are key to the FDA’s action plan, include the publication of a final rule and frequently asked questions documents for patients and health care providers explaining more about the transition.

The final rule, “Definition of the Term ‘Biological Product,’” amends the FDA’s regulation that defines “biological product” to incorporate changes made by the Biologics Price Competition and Innovation Act of 2009 (BPCI Act) and the Further Consolidated Appropriations Act, 2020, and to codify the FDA’s interpretation of the statutory term “protein.” Under this interpretation, the term “protein” means any alpha amino acid polymer with a specific, defined sequence that is greater than 40 amino acids in size. This interpretation is intended to clarify the statutory framework under which such products are regulated.

The FDA’s interpretation of the transition provision of the BPCI Act is intended to balance innovation and competition and facilitate the development and approval of biosimilar and interchangeable products. Getting safe and effective biosimilar and interchangeable products approved will help ensure that the market is competitive, and patients may have more affordable access to the treatments they need.

The agency also issued two frequently asked questions documents, one for patients and another for health care providers, with information on what the transition means to them. These documents clarify that the transition should not affect existing prescribing or dispensing practices and that patients should not notice any difference in their medications, or how they receive their medications, among other topics.

The FDA continues to work diligently to ensure there is a seamless transition between regulatory pathways and that there are minimal impacts on manufacturers and patients.

Posted on the FDA website on 20 February 2020