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Around 8 million people in the United States rely on insulin to manage their diabetes, but steady price increases have made the life-saving medicine increasingly more difficult to afford. As many as one in four insulin users have reported having to skip doses or use less of the drug than prescribed for cost reasons.
Recent measures by Congress cap monthly out-of-pocket costs at $35 for Medicare recipients, and insulin-makers have cut their list prices for certain products, but not all patients stand to benefit.
One biotech startup, rBIO of Houston, is aiming to make insulin more affordable by producing a copycat version of the drug—known as a biosimilar. It’s not the only company developing biosimilar insulin, but it says it has invented a new process to do so using custom-made bacteria.
CEO Cameron Owen says his company has created novel strains of bacteria that can produce insulin at twice the yield than is currently possible. Thursday, rBIO announced it had completed lab tests of its biosimilar insulin to determine that it is structurally and functionally similar to a brand-name one. It plans to begin a clinical trial later this year to determine whether its insulin works as well as a product already on the market.
“The high price of insulin is nothing short of price gouging,” Owen says. A 2020 estimate by the RAND Corporation put the average list price of a vial of insulin at $98 in the US compared with $12 in Canada and $7.52 in the UK.
Insulin is a naturally occurring hormone that the pancreas makes to regulate blood sugar. Companies manufacture synthetic versions for people with diabetes, whose bodies don’t make enough of it.
Three manufacturers have long dominated the US insulin market—Eli Lilly, Novo Nordisk, and Sanofi. These companies set the list prices for insulin and work with intermediaries called pharmacy benefit managers, or PBMs, to get their products covered by health insurance plans. Drug manufacturers often pay PBMs rebates or offer discounts to get a prime placement. As rebates got larger, insulin manufacturers raised their list prices to keep up. Patients, meanwhile, don’t benefit from these rebates. The practice has helped fuel the increase in insulin prices.
Before insulin’s discovery in 1921, people with diabetes didn’t live long. A 14-year-old boy dying from diabetes was the first to receive an injection of insulin in 1922. From then on, cattle and pigs were used to supply insulin for humans, but the animal hormone often caused allergic reactions in patients.
In 1978, scientists figured out how to make synthetic human insulin in the lab. They inserted the human insulin gene into bacteria to get them to start churning out the human version.
The process is complex, and up until recently, competitors couldn’t make generic versions of it even if they wanted to. Though insulin was first patented in the 1920s, manufacturers managed to keep it under patent protection by making incremental improvements to their insulin products over the years.
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Now some key patents have expired, and the US Food and Drug Administration (FDA) has paved the way for biosimilar versions of insulin—so-called because they’re almost identical to another product already on the market. For a product to be biosimilar, it must be highly similar in structure to the original and work just as well in patients.
Owen’s company, founded in 2020, has designed supercharged E. coli-like bacteria that can produce much greater amounts of insulin than existing strains used in insulin production. To do that, the company struck up a collaboration with Sergej Djuranovic, a professor of cell biology and physiology at Washington University School of Medicine in St. Louis. In 2019, Djuranovic's lab discovered a sequence of amino acids—the building blocks of proteins—that could make a gene produce far more proteins than is usual. He and his colleagues found that the sequence worked in bacterial, yeast, and even human cells.
“This sequence of certain amino acids will boost up protein production, and it’s purely because the protein is being made more efficiently,” Djuranovic says.
In theory, the sequence could be used to pump out large amounts of any protein, including insulin. Being able to produce insulin more efficiently is why rBIO thinks it can drive the cost down.
A 2018 study estimated that it costs roughly $2 to $4 to produce a vial of synthetic insulin. Owen says rBIO can do it even more cheaply, since its process yields more of the drug.
“New technologies that will make it even less expensive are certainly good, but they’re not going to be huge game changers right away,” says Robert Lash, a diabetes expert and chief medical officer of the Washington, DC-based Endocrine Society. Ultimately, he thinks more competition will be better for patients. “The more companies that are making insulin and the more options patients have available, the less expensive it’s going to become over time,” he says.
Even with the FDA’s blessing, few players outside the big three insulin manufacturers have broken into the market. In July 2021, the drug Semglee from Mylan Pharmaceuticals and Biocon Biologics became the first biosimilar insulin approved by the FDA, as an interchangeable product for Sanofi’s Lantus insulin. Later that year, the agency approved Rezvoglar by Eli Lilly as a biosimilar for Lantus, made by Sanofi. The three major insulin makers have also come out with unbranded versions of their own brand-name insulins.
Utah-based Civica, a nonprofit pharma company, announced plans in 2022 to manufacture and distribute its own low-cost insulin, pledging to cap prices at $30 per vial and $55 for a box of five cartridges. Last year, California entered into a contract with Civica so that the state could produce its own affordable insulin.
Owen says rBIO is aiming to reduce the cost of insulin by 30 percent. Its product, R-biolin, is designed to be a copy of Novo Nordisk’s Novolin, a fast-acting insulin that starts working within 30 minutes and lasts for 8 hours. This month, Novo Nordisk lowered the list price for several of its branded and unbranded insulins, including Novolin. It now charges $48.20 for a vial and $91.09 for a FlexPen of Novolin.
The Houston startup still has to prove whether its insulin works as well as Novolin, and even then, rBIO will have little control over the price patients end up paying. Like other manufacturers, rBIO would sell its insulin to pharmacy benefit managers. “We still think we can lower the cost significantly,” Owen says.
Updated 4-19-2022 5:00 pm ET: The onset time and length of duration of Novo Nordisk’s Novolin was corrected.
