FDA seeks to clear hurdles for biosimilar insulin in attempt to cut costs for diabetes patients

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Mike Lawson prepares to inject insulin to control his Type 1 diabetes in Oakland, Calif. on April 16, 2019. With the cost of insulin skyrocketing and the availability unpredictable, Lawson and other patients are taking unusual measures, like hoarding or trading, to ensure they have enough of the medication on hand.

Mike Lawson prepares to inject insulin to control his Type 1 diabetes in Oakland, Calif. on April 16, 2019. With the cost of insulin skyrocketing and the availability unpredictable, Lawson and other patients are taking unusual measures, like hoarding or trading, to ensure they have enough of the medication on hand.

Paul Chinn /The San Francisco Chronicle

The Food and Drug Administration has been quietly paving the way to bring a cheaper type of insulin to market — an effort that could improve access to lifesaving medication for millions of Americans with diabetes.

The federal agency announced efforts this week to help make the development of “biosimilar” and interchangeable insulin products more efficient, which could ultimately bring them to the market more quickly. Biosimilar insulin mimics the therapeutic effects of brand-name insulins. Interchangeable products are biosimilar products that meet additional guidelines, according to the FDA.

Under the draft guidance released this week, biosimilar drugmakers could skip certain costly clinical trials if they meet certain conditions, including that the proposed product is close enough to one that’s already on the shelves. The guidance clarifies what data and information would be needed to get FDA approval.

Increasing market competition among insulin products could potentially lower costs for patients and payers, such as insurance companies and government agencies, while increasing access and product choice, acting FDA Commissioner Dr. Brett P. Giroir said in a statement.

The U.S. insulin market is currently dominated by three manufacturers — Eli Lilly, Novo Nordisk and Sanofi. Between 2012 and 2017, prices for insulin products have doubled on average, according to the Health Care Cost Institute, an independent, nonprofit research group in Washington.

Last week, Harris County sued the three biggest insulin manufacturers and four pharmaceutical benefit managers, accusing them of colluding to set artificially high prices for the medicine and other diabetic treatments.

Houston-area officials allege that the 15-year scheme cost taxpayers millions of dollars through higher health care costs for employees, their dependents and inmates in the Harris County Jail. The county is seeking to recoup at least $27 million.

Novo Nordisk said in a statement that it disagreed with the allegations and would vigorously defend itself against the claims. Sanofi declined to comment; Eli Lilly did not respond to a request for comment.

At a May 13 hearing, Dr. Ned Sharpless, then acting FDA commissioner, highlighted a finding by the Congressional Research Service that a list price of one type of insulin had increased nearly 600 percent from 2012 to 2016.

“It hardly needs to be said that these kinds of whopping and steady price increases make it increasingly difficult for many insulin-dependent patients to afford basic medicines they need to survive,” he said. “As a physician, I find this intolerable. No patient should have to choose between paying for their medicine and paying for their rent.”

Sharpless, who is now director of the National Cancer Institute, also mentioned growing reports of diabetic patients stockpiling insulin and cases of people who died while rationing insulin. Such reports have made insulin the poster child of the drug pricing debate over the past several years.

Although letting drugmakers skip clinical trials might seem like a counterintuitive move for an agency tasked with the responsibility of regulating drugs and medical devices, the process has been a careful one, said Jeremy Sharp, managing director with Waxman Strategies, a lobbying firm based in Washington. He was the FDA’s deputy commissioner for policy during the Obama administration.

“The FDA has been trying to figure out what is the amount of evidence they need to feel comfortable saying to the public that these products are safe and effective,” he said.

A person has diabetes when their pancreas either does not make insulin or cannot properly use the insulin that their body does create. If not appropriately treated, this condition can lead to life-threatening complications, including heart disease, organ failure and blindness.

The prevalence of diabetes in Texas has increased 40 percent over the past decade, and the number of people with diabetes is projected to reach nearly 8 million by 2040, according to a new report by the Texas Diabetes Council.

Health policy experts say an abbreviated regulatory pathway for biosimilars could bring more competition similar to what has happened with the introduction of generic drugs.

The Hatch-Waxman Act, passed in 1984, allowed generic drug manufacturers to piggyback on the clinical trials of the drugs they replicate after the five-year market exclusivity period expires. But biologic medicines have been subject to different rules. Biologic medicines are advanced drugs, such as insulin and vaccines, made from living organisms or their products.

The U.S. regulatory pathway for biosimilars wasn’t developed until 2010, when it was written into the Affordable Care Act. Since then, Congress has been pushing the FDA to put in place the foundational regulations and guidance for these products known as “follow-on” biologics.

Health policy experts say it’s too early to tell whether the regulatory changes will be able to reduce the cost of insulin.

Potential obstacles include the possibility of patent litigation and existing contractual arrangements with brand-name drugs. In addition, it’s unclear how insurance companies would treat biosimilar insulins when deciding which drug products would be covered.

Senior researcher Jean Fuglesten Biniek at the Health Care Cost Institute said it’s possible that other policy interventions will be necessary to reduce the financial burden on people who rely on insulin to live.

Laura Garcia covers the health care industry in the San Antonio and Bexar County area. Read her stories and more local coverage on our free site, mySA.com, and on our subscriber site, ExpressNews.com. | laura.garcia@express-news.net | Twitter: @Reporter_Laura