FDA Hears From Stakeholders About Insulin Transition to Biologic Pathway in 2020

Set against a backdrop of rising concern about the cost of insulin, the FDA held a hearing about biosimilar insulins Monday, 10 months before the products transition in March 2020 from the Food Drug and Cosmetic (FD&C) Act to biologics under the Public Health Service (PHS) Act.

The meeting also came a few days after the FDA released interchangeability guidance for biosimilars. According to remarks made by FDA Acting Commissioner Ned Sharpless, MD, the guidance will help keep prices low, while the transition to a new approval process will speed insulin competition.

The FDA workshop heard from a variety of stakeholders, including Vizient, Inc; Eli Lilly, maker of insulin lispro; Mylan; the JDRF; the American Diabetes Association; and Christine Simmon, of the Association for Accessible Medicines, to name a few.

“We encourage the FDA to build on its significant experience with insulin and foster efficient development of biosimilar insulins to lower costs and increase access for America’s diabetes patients,” said Simmon. “We urge the agency to continue educating providers and patients that transition from a reference product to a non-interchangeable biosimilar will not result in changes to safety or effectiveness.”

Those testifying gave different perspectives depending on their relationship to insulin, as noted in one report.

Mylan, which has so far tried and failed to get FDA approval for a follow-on insulin glargine referencing Lantus, said that the FDA should allow regulators to use previous trial findings or published literature in order to approve a follow-on product.

Meanwhile, Eli Lilly, which makes an insulin lispro injection (Humalog) and recently announced an authorized generic, called for switching studies and said that it gives more backing to the idea that the follow-ons will not generate immunogenicity.

Others testifying at the meeting explained how patients switch between insulins currently, which prompted the issue as to why interchangeable insulins and follow-on, or insulin biosimilars, need to reside in 2 separate categories.

Mariana P. Socal, MD, an assistant scientist at the Johns Hopkins Bloomberg School of Public Health, said there might be unintended consequences with the 2 separate designations, which patients might find confusing, according to S&P Global Market Intelligence.

For her part, Simmon, of AAM, drew similarities between insulin issues and the biosimilar market overall. “The insulin market in the US is a direct reflection of issues facing biosimilar broadly. The current insulin market lacks significant competition to the detriment of patient access and health and has been characterized as a public health crisis,” she said in her remarks.

“The combination of regulatory challenges, over-patenting to stave off competition, and anti-competitive rebating and contracting tactics by brand firms has been the cause of the lack of competition,” she said. Increases in list price impact insulin affordability, Simmon noted, affecting patient adherence.

Six of the most highly-used brand name insulins increased in list price by more than 500% from 2006 to 2015, she said.

The nation’s largest group purchasing organization, Vizient, said it fully endorses the scientific principles of biosimilarity, and “we believe that molecules necessary to create insulin are well suited for the creation of a biosimilar option for providers and patients,” according to a statement from Steven Lucio, PharmD, BCPS, vice president, pharmacy solutions.

“Insulin biosimilars, once approved, will bring much needed, new competition to the market and will offer more affordable treatment options to patients with diabetes.”