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.
Biosimilar insulin in the United States
In other parts of the world, including Europe and Asia, insulins have been approved through the biosimilar pathway. However, in the U.S. these products have gone through a different FDA approval process and are called a ‘follow-on product.’ FDA rule changes scheduled to take place in early 2020 will merge these two processes so that a biological product approved as a drug will be classified the same as other licensed biological products.
There are currently two follow-on insulin products available for use in the United States. The first in 2015 was a long-acting insulin, Eli Lilly and Company’s Basaglar (insulin glargine injection) with the reference product being Sanofi-Aventis’s Lantus (insulin glargine injection). Additional long-acting injection products have either received tentative approval from the FDA or have been approved and distributed in other countries, but have not yet become available in the U.S. In December of 2017, the FDA approved the first rapid-acting follow-on insulin product, Sanofi-Aventis’s Admelog (insulin lispro injection), reference product Eli Lilly’s Humalog (insulin lispro injection).
Diabetes clinical implications
You should expect no difference between taking a biosimilar or its reference product in how safe it is, how well it works or in your health outcomes. Due to small differences in the manufacturing process, rare, but serious, reactions of the immune system may occur when switching to a biosimilar or follow-on product.
Each state has different laws about whether a pharmacy is able to substitute a biosimilar for its reference product. Each state’s legislation addresses key biosimilar principles including how the products are FDA approved, if a prescriber decision is necessary for substitution, how a prescriber must be communicated with , how the patient is notified, what records must be kept, and if cost affects the decision.
A major contributor to increasing costs of prescriptions has been biologic products, insulin, cancer medications and monoclonal antibodies that are used for a variety of conditions such as rheumatoid arthritis and Crohn’s disease. If you take insulin, your out-of-pocket costs may have also increased.
Similar to generic drugs, biosimilar products may allow access to treatment at lower costs due to less in research costs and competition between manufacturers to drive price decreases. Other countries have seen treatment costs decrease by up to 40 percent due to biosimilar products. It is still unknown if the biosimilar pathway will reduce costs of insulin in the United States; however, a recent study estimated that biosimilar products including insulins will decrease spending on biologic drugs by $54 billion between 2017 and 2026 in the United States.
The Biologics Price Competition and Innovation Act has allowed for biosimilar products to enter the drug market in the United States. These products are not the same as a generic drug, but do offer similar benefits in terms of potential decreases to the cost of medications and patient access. The approval of biosimilar or follow-on products with the FDA gives you and your diabetes care team assurance these products are safe and effective.
Want to learn more about insulin? Read “What Does Insulin Do?” “Insulin: What You Need to Know” and “Everything You Ever Wanted to Know About Injecting Insulin.”