Scott Gottlieb, Commissioner of the US Food and Drug Administration is focusing on insulin drugs in the current round of the government’s efforts to lower pharmaceutical prices. 

For a product nearly 100 years old, Gottlieb said drugmakers are charging too much, which forces diabetes patients to ration their drugs and sacrifice their health for financial reasons. In some cases, he asserted, patients have died because they couldn’t afford the needed injections.

Speaking at a pharma forum last week, the commissioner said that from 2020 onward, the FDA plans to reclassify insulin products as biologics, rather than as drugs.

Evoking a “watershed moment,” Gottlieb said the new classification will allow manufacturers of biosimilars to develop their own versions of insulins that can be substituted at the pharmacy. This, he said, would create competition and lower costs.

Up to now, it has been hard to bring a substitutable generic insulin to the market under the conventional drug pathway, the FDA chief added. “The biosimilar pathway should make this kind of competition more accessible.”

The  agency is concerned that three drugmakers control all of the US insulin supply, and, as Gottlieb put it, “prices in the category have grown dramatically in recent years.” According to one study he cited, list prices for four insulin categories grew 15% to 17% per year from 2012 to 2016. A second study found that list prices for one type of insulin grew 600% over 14 years.

Some experts expressed skepticism that the FDA’s price-cutting drive will have a major impact, in particular as they say there already are insulin options available. Even though the insulin market is relatively small compared to other widely used medications, the drugs that do exist limit the potential size for a generic insulin market, commentators said.

According to Andrew Mulcahy, a policy researcher and associate director of the economics, sociology and statistics department at RAND Corp in a 2017 analysis, the switch to biosimilars could potentially generate cost savings of $54 billion over the next 10 years, but this is roughly half the discounts of other biosimilars.

Separately, French drugmaker Sanofi – one of the top three insulin drug manufacturers – has blamed its plummeting revenues from sales of its diabetes drug Lantus, for which the patent has expired. Sanofi is cutting jobs at its main insulin production site in Frankfurt, Germany, and reducing its sales force in the US.

A recent win for generics producer Mylan, which manufactures a copy of Lantus, has added to the French company’s woes. A ruling by the US Patent and Trademark Appeal Board (PTAB) in favor of the Netherlands-domiciled company drugmaker with an operative base in the UK and a focus on the US market, rejected all claims of Sanofi's Lantus formulation patents.

Lantus is facing increasing competitive pressure at the payer level and from biosimilars in several European markets and Japan. In the US, Eli Lilly and Boehringer Ingelheim launched Basaglar, a follow-on to Lantus in the US market in 2016.