Semglee, a Biosimilar Insulin to Glargine, Receives FDA Approval

With the introduction of the new biosimilar insulin Semglee, patients with diabetes will have the opportunity to have easier and broader access to insulin therapy, and a more affordable option than those already on the market. 

On July 28, 2021, the U.S. Food and Drug Administration (FDA) approved the biosimilar insulin under the name Semglee (insulin glargine-yfgn). Semglee is a long-acting insulin, and due to its extended duration properties within the body, it only needs to be administered once daily subcutaneously. It is available in 10 mL vials and 3 mL prefilled pens. This medication also has received approval for use in adults and pediatric patients with type 1 diabetes and adults with type 2 diabetes. What separates Semglee from other insulins already on the market is that it is the first interchangeable biosimilar insulin. This specific characteristic of Semglee allows it to be a replacement for insulin glargine, also known as Lantus, due to there being no clinically significant differences between the two. This statement also means that patients can count on Semglee being just as effective and safe as Lantus.

Expanding on what it means for Semglee to be a biosimilar product of Lantus, the FDA required substantial evidence that proved Semglee shared almost indistinguishable safety profiles and clinical results. The reason behind these strict standards was so that, if a patient were switching between both Lantus and Semglee, there would be no decline in the effectiveness against type 1 or type 2 diabetes. In addition, the makers had to ensure that the patients were not at a greater risk because of the switching between both products compared to a patient that was solely using Lantus to manage their diabetes. Finally, the benefit of having proved that Semglee is nearly identical to Lantus allows patients to have their Lantus replaced with Semglee at their local pharmacy without needing to contact the patient’s prescriber for approval of the substitution, depending on the state laws. 

While it is an achievement to have the first biosimilar insulin enter the market to compete with its competitors, how does this benefit patients aside from adding a replacement for Lantus? The answer is: it allows patients to buy a cheaper alternative to Lantus without compromising the safety and effectiveness of Lantus. According to GoodRx, Semglee has a cash price as low as $149.39 per carton (Five 3 mL pens) if the patient is in the Savings Club, or $154.02 per carton if the patient uses GoodRx’s free coupons. Both are good options if patients are looking for lower-cost options for Lantus. In contrast, Lantus, according to GoodRx, goes as low as $336.15 per carton (Five Solostar pens) with the GoodRx free coupons, or as low as $435.56 if the patient enrolled in the Savings Club. Adding another comparison is Basaglar, another insulin glargine product. Basaglar is priced as low as $250.91 per carton (Five 3 mL pens) using GoodRx’s free coupons, with no Savings Club option currently available.

Taking price into consideration, Semglee is a more cost-effective option compared to Lantus and Basaglar. When considering the previously mentioned prices, a patient could buy two cartons of Semglee to a single box of Lantus when both have the same safety profile and effectiveness against diabetes. Long term, patients could save plenty of money by choosing to go with Semglee instead of Lantus.

Patients that use Semglee should be aware that it could cause the same common adverse effects such as edema, lipodystrophy, weight gain, and allergic reactions. This concept also applies to severe adverse events seen in insulin glargine, such as hypoglycemia, hypokalemia, heart failure, or patients who have had anaphylactic reactions to previous insulin glargine products.

In conclusion, Semglee has opened the gates to provide patients with a cheaper alternative to Lantus with a seamless transition between the two medications due to not needing prescriber approval of the substitution. Not only is this biosimilar cheaper than Lantus, but it proved to be as safe and effective, so patients do not have to compromise on the cheaper alternative. While this impacts only patients on the basal insulin Lantus, when dealing with a lifelong condition such as diabetes, this is the first step toward supplying patients with more affordable insulin products.

Practice Pearls:

• Semglee is an interchangeable biosimilar insulin that can switch with Lantus without the need of the prescriber.
• Semglee has the same degree of safety and effectiveness as Lantus.
• Semglee provides patients a cheaper alternative to Lantus without compromising the benefits of glycemic control.

“FDA Approves FIRST Interchangeable Biosimilar Insulin Product for Treatment of Diabetes.” U.S. Food and Drug Administration, FDA, July 28, 2021

“Prescription Prices, Coupons & Pharmacy Information.” GoodRx, www.goodrx.com/.

Alan Martinez, PharmD Candidate, University of South Florida Taneja College of Pharmacy