FDA vs. Smooth Regulatory Transition of Insulin

Now, the U.S. Food and Drug Administration took extra steps to secure a smooth regulatory change aimed at improving patient access to insulin results used daily by millions of Americans to have stable blood glucose levels, as well as some other biological effects set to transition administrative pathways in March. Today’s actions involve issuing a final rule and supplementary sources to provide useful data to stakeholders, including industry, patients, and health care providers.

On March 23, 2020, an appeal for a natural result approved under the Federal Food, Drug, and Cosmetic Act (FD&C Act), including applications for insulins and other physical products, will be considered 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 a biosimilar to, or interchangeable with, the transitioned products.

As such, the transition of insulin results from certified drug applications to considered biological stock licenses will open up those products to possible biosimilar and interchangeable game. The availability of licensed biosimilar and interchangeable insulin results is expected to increase patient access, adding more choices, and possibly reducing the costs of insulin products.

The Upcoming Changes

“Biologic medicines are often multiple therapies that can be used to treat some of the most serious diseases, including autoimmune disorders, rare genetic disorders, and diabetes. Life-sustaining insulin results are biologics, but to date, there has been insufficient competition in the marketplace, resulting in fewer choices and higher prices for sufferers.

This change will open new pathways for manufacturers to make biosimilar and interchangeable variants of insulin and other transitioning commodities to market, promoting greater engagement in the marketplace,” said FDA Commissioner Stephen M. Hahn, M.D.

“These significant treatments often carry a heavy price tag; the cost of insulin has risen over the past decade. Opening these results to the heightened competition is supposed to bring down prices and help sufferers have a way to more choices for these life-saving drugs. We will proceed to communicate important news, including the resources we’ve issued today, to make the transition from one statutory framework to another as seamless as feasible.”

The FDA has taken many measures to date to build the framework for this new pathway, including publishing the 2018 Biosimilars Action Plan (BAP), which aims to improve the performance of the biosimilar and interchangeable commodity development and support process and to maximize scientific and regulatory clarity for the biosimilar product development center.

Current Activity

The agency has performed many of the projects described in the Biosimilars Action Plan. It is extending our work on others to enhance patient access to required medicines in the period leading up to the transition.

Today’s actions, which are essential to the FDA’s action plan, include the publication of a final rule and often requested 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 “natural 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 account, the name “protein” means any alpha amino acid polymer with a unique, 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 plan of the BPCI Act is intended to balance innovation and competition and facilitate the development and endorsement of biosimilar and interchangeable commodities. Getting safe and efficient biosimilar and interchangeable goods approved will help ensure that the market is competitive, and patients may have more affordable access to the medicines they need.

The agency also announced two frequently asked questions documents, one for sufferers and another for health care providers, with data on what the transition means to them. These reports clarify that the development should not affect living prescribing or dispensing practices and that sufferers should not notice any variation in their medications, or how they receive their vaccinations, among other topics.

Wrapping Up

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

The FDA, an agency within the U.S. Department of Health and Human Services, preserves the public health by assuring the safety, effectiveness, and confidence of human and veterinary medicines, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, results that give off electronic radiation, and for regulating tobacco products.