A startup has discovered a way to make cheap insulin

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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 are almost identical to another product already on the market. For a product to be biosimilar, it must have the same composition as the original and also work well in patients.

Owen's company, founded in 2020, has designed the supercharged e coli-like bacteria that can produce insulin in much higher quantities than existing strains used in insulin production. To do this, the company collaborated with Sergej Juranovic, professor of cell biology and physiology at Washington University School of Medicine in St. Louis. In 2019, Juranovic's lab discovered a sequence of amino acids – the building blocks of proteins – that can cause a gene to produce far more protein than normal. He and his colleagues found that the sequence works in bacteria, yeast and even human cells.

“This ordering of certain amino acids will boost protein production, and this is purely because the protein is being made more efficiently,” says Juranovic.

In theory, the sequence could be used to pump large amounts of any protein, including insulin. By being able to produce insulin more efficiently RBIO thinks it can reduce costs.

A 2018 study estimated that it costs about $2 to $4 to produce a vial of synthetic insulin. Owen says rBIO can do this even more cheaply, because its process yields more drug.

“New technologies that will make it even less expensive are certainly nice, but they're not going to be huge game changers right away,” says Robert Lash, MD, a diabetes expert and chief medical officer of the Washington, D.C.-based Endocrine Society. Ultimately, he believes more competition would be better for patients. “The more companies making insulin and the more options available to patients, the less expensive it will become over time,” he says.

Even with the FDA's blessing, few players outside the big three insulin makers have entered the market. In July 2021, Mylan Pharmaceuticals and Biocon Biologics' drug Semgli 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 to Lantus, made by Sanofi. The three major insulin manufacturers have also come out with non-branded versions of their own brand-name insulins.

Utah-based Civica, a nonprofit pharma company, announced plans to manufacture and distribute its own low-cost insulin in 2022, setting a price of $30 per vial and $55 for a box of five cartridges. Was promised. Last year, California signed a contract with Civica so the state could produce its own affordable insulin.

Owen says rBIO aims to reduce the cost of insulin by 30 percent. Its product, R-Biolin, is designed as a copy of Novo Nordisk's Novolin, an insulin that starts working within 90 minutes and lasts for up to 24 hours. This month, Novo Nordisk reduced the list prices for several of its branded and non-branded insulins, including Novolin. It now charges $48.20 for a vial and $91.09 for Novolin's FlexPen.

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 pay. Like other manufacturers, RBIO will sell its insulin to pharmacy benefit managers. “We still think we can reduce costs significantly,” says Owen.