FDA publishes final guidance to streamline biosimilar insulin development
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The FDA on Thursday published a final rule outlining the application process for a new pathway for biological products, including biosimilar insulins, part of a larger effort to streamline the approval of more follow-on agents, spur competition and reduce costs, according to an agency press release.
Beginning March 23, an application for a biological product approved under the Federal Food, Drug, and Cosmetic Act, including applications for insulins, will be deemed to be a license for the product under the Public Health Service Act. For the first time, this will enable the submission of applications for biosimilar products that are proposed as interchangeable with the reference products.
Currently, any follow-on insulins must be approved under the abbreviated new drug pathway; they are not considered to be “biosimilar” because insulins are approved and regulated as chemical drugs, according to the FDA.
In announcing the formal transition, the FDA stated that the change will open up insulins and other products to potential biosimilar and interchangeable competition, adding more choices and potentially driving down the cost.
“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,” FDA Commissioner Stephen M. Hahn, MD, said in the release. “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.”
Growing concern
As Healio previously reported, insulin prices, which tripled from 2002 to 2013, continue to climb, nearly doubling between 2012 and 2016, according to 2017 data from the Health Care Cost Institute. During that same period, the average list price of the four insulin categories — short-acting insulin, long-acting insulin, rapid-acting insulin vials and rapid-acting insulin pens — increased between 15% and 17% per year, according to data from the American Diabetes Association’s Insulin Access and Affordability Working Group, published in 2018.
There are currently two biosimilar insulins approved in the U.S. — Basaglar (Lilly), a follow-on to insulin glargine (Lantus, Sanofi) approved in 2015, and Admelog (Sanofi), a follow-on to insulin lispro (Humalog, Lilly) approved in 2017.
Hahn said opening insulin products to increased competition is expected to bring down prices and help patients have access to more choices.
“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,” Hahn said in the release.
The FDA has taken other steps to date to establish the framework for this new pathway, including issuing the 2018 Biosimilars Action Plan, 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.
Addressing concerns
In addition to the final rule, the FDA also published “frequently asked questions” documents for patients and health care providers that further explain the transition.
“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 agency stated in the release.
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 and the Further Consolidated Appropriations Act, 2020, and to codify the FDA’s interpretation of the statutory term “protein,” according to the agency. 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 agency stated in the release.
In the release, the FDA stated that it will work to ensure a “seamless transition” between regulatory pathways and a minimal effect on manufacturers and patients. – by Regina Schaffer
Reference:
FDA. 2018 Biosimilars Action Plan. Available at: https://www.fda.gov/media/114574/download. Accessed Feb. 20, 2020.
Disclosure: Hahn is commissioner of the FDA.