Americans are concerned about the rising cost of prescription medications. This is especially true for people who have diabetes. In fact, individuals with diabetes have 2.3 times higher health-care costs than those without diabetes. Additionally, one in seven health-care dollars is spent on diabetes and its complications. Health-care professionals and people with diabetes know that a large portion of the costs are medications for diabetes.
Many medications have less expensive generic versions, so you may wonder when generic insulin will be available. The answer is complicated, but offers some hope for reducing the cost of insulin. And in fact, according to a recent announcement by insulin manufacturer Eli Lilly, generic insulin may be closer than we think.
The U.S. Food & Drug Administration (FDA) is responsible for regulating food, medications, medical devices, cosmetics and tobacco products. Over time, there have been laws that have changed what the FDA does and how it does it. One of those laws was the Biologics Price Competition and Innovation Act passed by the U.S. Congress in 2009. This legislation created a new way for biologic medications, such as insulin, to be approved and sold in the United States. To understand how this happens, it’s important to understand some definitions:
• Biological product: A category of medications that are generally made of large, complex molecules. Because these products contain such complex molecules, it cannot be guaranteed that all of the products are exactly the same when looking at the molecular structure.
• Reference product: A product approved by the FDA after a thorough assessment to make sure it is both safe and effective. When a biosimilar product is going through the FDA review process, this is the product to which the biosimilar product is compared.
• Biosimilar product: A biological product that is highly similar to and considered to have no difference that would change what you expect from the reference product.
• Generic drug product: A medication that has an active drug ingredient exactly the same as the brand name medication previously approved by the FDA.
FDA approval process
For approval as a biosimilar product, manufacturers must show the FDA that the product is comparable to the reference product in several ways including the 1) purity of the product, 2) chemical identity and 3) how it works inside the body. Studies have to show the FDA that there are no differences in the products in how safe the product is or how well it works.
While biosimilars may be thought of as ‘generics’ of their reference products, this is not technically true. Both generic drugs and biosimilar products are able to go through a shorter approval process with the FDA. However, generic drugs approved by the FDA are required to have the same active ingredients and no difference in how it works inside the body when compared to their brand name counterparts.