FDA Approves Interchangeable Biosimilar Insulin to Potentially Reduce Cost for People to Treat Diabetes
Reaction from the UMass Diabetes Center of Excellence
Date Posted: Friday, July 30, 2021
On July 28, 2021, the U.S. Food and Drug Administration (FDA) approved the first interchangeable biosimilar insulin product as a substitute for Lantus, a long-acting insulin analog. It’s the first interchangeable biosimilar product approved in the United States for the treatment of diabetes.
“This ultimately empowers patients by helping to increase access to safe, effective and high-quality medications at potentially lower cost,” said Acting FDA Commissioner Janet Woodcock, MD.
A biosimilar is a biological product that is highly similar to, and has no clinically meaningful differences from, a biological product already approved by the FDA. An interchangeable biosimilar product may now be substituted for Lantus by pharmacies without the intervention of the prescribing physician. Such pharmacy-level substitutions of generic drugs have been a regular practice for years, subject to pharmacy laws which vary by state.
Biosimilar products have the potential to reduce health care costs, similar to how generic drugs have reduced costs. Biosimilars marketed in the U.S. typically have launched with initial list prices 15% to 35% lower than comparative list prices of the reference products.
UMass Diabetes Center of Excellence (DCOE) Education Manager Cheryl Barry, RN, is cautiously optimistic. As a certified diabetes care and education specialist (CDCES), she and her fellow diabetes educators often hear complaints that insulin is too expensive. Many people even admit to skipping doses to make it last longer.
“If the cost is truly significantly lower as most generics are, then our patients with high deductibles, Medicare patients in the donut hole, and uninsured patients who ration their insulin or don’t taking it at all, will now be able to get their required medication,” said Barry.
“It’s too soon to say if this product will help our patients combat the insulin affordability issue,” said Dr. Samir Malkani, Clinical Chief, Division of Endocrinology & Diabetes, UMass Memorial Health and UMass Chan Medical School. “We already have many choices for long-acting insulins, yet, despite the competition, prices remain sky high. Once the biosimilar hits pharmacy shelves, we should be in a better position to assess the costs and insurance coverage.”
All biological products are approved only after they meet the FDA’s rigorous approval standards. They will continue to monitor the safety and efficacy of the biosimilar insulin.
“Insulin is not a luxury but a necessity for millions of people, yet the cost of this life-saving medication can be astronomical and devastating to families,” added Barry. She and other healthcare professionals feel that once an insulin product is off patent, the price should be lowered to a reasonable amount, so nobody is deprived of obtaining their prescribed insulin.
Dr. Malkani agrees. “There needs to be more laws capping out-of-pocket costs for insulin,” he said. “Insulin is 100 years old, and the prices keep going up because the pharmaceutical industry realizes it’s a life-sustaining medication for people with diabetes.”
In 2019, Colorado became the first state to pass into law an insulin copay cap, spearheaded by Rep. Dylan Roberts in memory of his late brother who lived with type 1 diabetes. On January 1, 2020, a $100 cap for a 30-day insulin supply went into effect in Colorado. Since then, seven other states have enacted legislation to help with insulin affordability. Caps are as low as $35 for a month’s supply in Maine and $25 in Utah, however, 42 states still do not have such laws.