Regulations keep insulin expensive
Insulin is a biologic drug, which means it’s produced by a living organism, not a chemical reaction. This process, called biomanufacturing, is more inconsistent than chemical synthesis of non-biologic drugs like aspirin.
Making reliable biologic drugs is a little like winemaking. Even though the winemaker carefully follows a well-established process, minute differences will affect the final product. It’s always wine, but some vintages are better than others and tasting the wine is the only way to evaluate the final product.
So if a new company wants to make insulin, that insulin has to be tested on patients in expensive clinical trials. Bringing a biologic drug to market can cost as much as $250 million. No company can afford that lump if it can’t file for a patent to recoup the investments.
That’s why there’s only one “generic” insulin available so far. It’s made by a company that was already a major player in the insulin market, and it’s only 15 percent cheaper than the patented version. By comparison, most non-biologic generic drugs cost 80 percent less than the original.
Obviously, regulations are important for keeping insulin safe, but at what cost? Ten percent of people living with diabetes in the U.S. are uninsured, and there are nearly 10,000 crowdfunding campaigns related to insulin on the site GoFundMe alone. Stories about diabetic patients ending up hospitalized or worse because they tried to ration their insulin are all-too common.
Democratizing Insulin Production
As in winemaking, the specific know-how required for insulin production is a guarded secret. The goal of the Open Insulin Project is to figure out a patent-free method and release the information, so that competing companies can manufacture “generic” insulin.