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FDA’s Gottlieb proposes biosimilar pathway to tackle skyrocketing insulin prices

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A patient loads insulin for his routine shot.

Amid its efforts to support biosimilars, the Food and Drug Administration is wading into one of the most hot-button segments of the ongoing national debate over drug pricing: insulin.

In a statement Tuesday, FDA Commissioner Scott Gottlieb outlined a new regulatory pathway designed to promote biosimilar competition for marketed insulin products. The price of insulin – access to which is a matter of life and death for patients with diabetes, particularly Type 1 diabetes – has become one of the most critical aspects of the drug-pricing conversation.

The high price of insulin has resulted in many patients rationing the drug, a practice that can have deadly consequences, most notably from diabetic ketoacidosis, whereby high blood sugar turns the blood acidic and causes the body to stop functioning.

“Given our long experience regulating insulin products, and high interest among sponsors who are proposing to develop interchangeable insulins, we’re confident that interchangeable insulins – insulins that will be available for automatic substitution at the pharmacy level – will be attainable after the trasition to deemed BLAs in March 2020,” Gottlieb wrote, referring to Biologic License Applications, which companies use to apply for FDA approval of biotech drugs. He acknowledged that such a guidance would not be soon enough for patients who struggle to pay for insulin today, but said the FDA was taking “other steps” to increase market competition.

Gottlieb pointed out that the Canadian doctor who discovered insulin in 1921, Frederick Banting, and his team sold the US patent for it two years later to the University of Toronto for $3. Yet, the FDA announcement cited a mid-November report by the Congressional Research Service stating that the price of insulin increased nearly 600 percent between 2001 and 2015, from $35 per vial to $234. And today, three companies control 90 percent of the global insulin market, including producing all the insulin sold in the US. That limited competition stands in contrast to advances in production, such as recombinant DNA technology allowing for efficient production that has existed since 1982.

The companies that make most of the insulin – namely French drugmaker Sanofi, Denmark-based Novo Nordisk and Indianapolis-based Eli Lilly & Co. – were investigated last year by attorneys general in multiple states, according to Kaiser Health News, along with pharmacy benefit manager CVS Caremark. One of them, Minnesota Attorney General Lori Swanson, sued the three drugmakers in October, alleging price gouging. Health and Human Services Secretary Alex Azar was formerly an executive at Lilly and has faced criticism due to the company dramatically increasing the price of insulin products during his tenure there. However, he also has stated that current insulin prices are too high.

Photo: eromaze, Getty Images

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