FDA Propels Insulin Affordability with Semglee
By Karena Yan
By Karena Yan, Joseph Bell, and Arvind Sommi
Semglee may provide a cheaper alternative to Lantus (insulin glargine) – it costs $148 for five pre-filled insulin pens.
Semglee, which was approved last year as a new basal insulin for adults and children with type 1 diabetes and adults with type 2 diabetes, has now been designated by the FDA as an “interchangeable biosimilar” insulin to Lantus (insulin glargine). This designation allows pharmacists to substitute the much cheaper Semglee for Lantus without having to consult the prescribing healthcare professional – providing a potentially more affordable alternative to drugs such as Lantus.
Semglee is available by prescription in either a pen or a vial – it costs $147.98 for five 3 mL pre-filled pens or $98.65 for one 10 mL vial, which is a 65% discount from the list price of Lantus. The actual out-of-pocket costs can differ dramatically since the list price does not consider discounts or rebates available with a variety of insulin brands.
For people who are uninsured or underinsured, or don’t qualify for patient assistance programs, Semglee represents a far more affordable option for people who take basal insulin. While biosimilars are usually not as inexpensive as “generic” versions of drugs, because biosimilars are more expensive to manufacture, they may provide cheaper alternatives to brand name drugs. Further, because Semglee has been deemed functionally equivalent to Lantus, it should provide an important and practical option for basal insulin users who are concerned about insulin costs. Semglee was previously approved as a biosimilar in 45 countries, including Australia, Japan, South Korea, and several European nations.
But what exactly is a biosimilar drug?
Drugs can either be a chemical compound or a biologic compound. When a company makes a brand new drug, they can get a patent that prevents competing companies from copying their drug for a certain amount of time. Once the patent expires, other companies can try to create their own version of the original drug. If the drug is a chemical compound, then it is relatively easy to copy – this is called a generic drug. If the drug is a biologic compound, like insulin, then it is more complex and harder to create an identical copy. However, competing companies can attempt to make an almost identical biologic drug that has the same effects as the original company’s drug – this is called a biosimilar drug. Additionally, if a biosimilar drug is designated as “interchangeable” with the original drug (Lantus), then (depending on your state’s laws) your pharmacist may be able to provide you with a cheaper biosimilar (Semglee) without having to get permission from the prescriber because the two drugs exhibit the same effects on the body.
Two biosimilar insulins are currently approved in the US: Basaglar, a basal insulin similar to glargine (Lantus) which was approved in 2016, and Admelog, a rapid-acting insulin lispro approved in 2018. The recent FDA approval is significant because Semglee is now the first interchangeable biosimilar insulin product.
Mylan is offering a co-pay discount card and a patient assistance program to help people afford Semglee. The co-pay card is available to people with commercial health insurance – you may be able to receive up to $75 off each 30-day prescription. Learn more here. People without prescription insurance coverage, you may be able to get Semglee for free. You can access the patient assistance program by calling Mylan customer service at (800)796-9526.