The U.S. Food and Drug Administration took action this week that should make it easier to get a lower cost near-copy of a brand-name insulin, Lantus, at the pharmacy.
Semglee has been approved as both biosimilar to, and interchangeable as a substitute for Lantus, a widely used long-acting insulin.
Biosimilar drugs are not the same as generic drugs. Unlike generic drugs, which share the same chemical composition as their pricier brand-name counterparts, biosimilar drugs are “highly similar” duplications.
Before year end, Semglee may be substituted for Lantus (the reference product) without the intervention of the prescribing doctor. The substitution may occur at the pharmacy, a practice commonly called “pharmacy-level substitution”— much like how generic drugs are substituted for brand name drugs.
Diabetes and insulin
I am one of 34 million people in the U.S. today diagnosed with diabetes, a chronic health condition that affects how the body stores and uses sugars for energy. Most food and especially carbohydrates is broken down into glucose and released into the bloodstream. When blood glucose (sugar) levels increase, the pancreas releases insulin, which acts to allow blood sugar to enter the body’s cells for use as energy. With diabetes, the pancreas doesn’t make enough insulin to keep sugar levels in the normal range. Diabetics like me inject dosages of insulin such as Lantus to offset the level of glucose in my bloodstream. (Of course, my doctor says lowering my carbohydrate intake and burning off the glucose – diet and exercise, would help, too.)
insulin and medicare
Beginning this past January, my Medicare clients have been able to get drug coverage for many types of insulin for no more than $35 for a month’s supply. This savings on insulin is through a Medicare Part D drug plan or Medicare Advantage Plan that participates in the insulin savings model. Clients enrolled in Medicare Extra Help or New York State EPIC program enjoy copay assistance as well.
I will be watching to see if the 2022 Part D and Medicare Advantage plan formularies include Semglee and, if so, whether Semglee will be included in this insulin savings model and what the cost to my Medicare clients will be. This is all very promising news.
Additional Resources: https://www.fda.gov/news-events/press-announcements/fda-approves-first-interchangeable-biosimilar-insulin-product-treatment-diabetes
https://www.prnewswire.com/news-releases/viatris-inc-and-biocon-biologics-receive-historic-approval-for-first-interchangeable-biosimilar-semglee-insulin-glargine-yfgn-injection-for-the-treatment-of-diabetes-301343915.html
https://www.drugs.com/history/semglee.html https://www.medicare.gov/coverage/insulin
https://www.cbsnews.com/news/fda-biosimilar-insulin-semglee-insulin-pen/