Short answer: The Semglee label says Semglee (insulin glargine-yfgn) is biosimilar to Lantus (insulin glargine).1 Both are 100 units/mL, injected once a day at the same time, for adults and children with diabetes, in a 10 mL vial and a 3 mL pen.2 The side-effect and trial tables on both labels come from the same insulin glargine studies against NPH insulin. Neither has a boxed warning.
| Semglee | Lantus | |
|---|---|---|
| What is in it | Insulin glargine-yfgn 100 units/mL1 | Insulin glargine 100 units/mL2 |
| Status on the label | Biosimilar to Lantus (insulin glargine)1 | Reference product1 |
| Approved for | Adults and children with diabetes1 | Adults and children with diabetes2 |
| Forms | 10 mL vial; 3 mL prefilled pen in 1-unit steps1 | 10 mL vial; 3 mL SoloStar pen in 1-unit steps2 |
| When injected | Once daily at any time, the same time every day1 | Once daily at any time, the same time every day2 |
| Starting dose, type 2 not on insulin | 0.2 units/kg or up to 10 units once daily1 | 0.2 units/kg or up to 10 units once daily2 |
| Upper respiratory infection, type 1 adults | 22.4% vs 23.1% on NPH (insulin glargine studies)1 | 22.4% vs 23.1% on NPH2 |
| Opened vial / pen | Vial 28 days, fridge or room temperature; pen 28 days at room temperature1 | Vial 28 days, fridge or room temperature; pen 28 days at room temperature2 |
| Missed dose | No instruction in the label1 | No instruction in the label2 |
The Semglee label defines biosimilar as approved on data showing it is highly similar to an FDA-approved reference product, with no clinically meaningful differences, for the uses, doses, strengths, forms and routes in its prescribing information. Its approval for children rests on that biosimilarity plus a study of insulin glargine in 174 children aged 6 to 15.1 The Semglee label does not use the word interchangeable.
The clinical tables on the Semglee label are insulin glargine studies against NPH insulin, the same numbers that appear in the Lantus label: for example, severe low blood sugar in 10.6% vs 15.0% of type 1 adults in Study A, and 5.6% vs 1.8% on standard care in ORIGIN.12
No. Both list low blood sugar as the most common reaction, with the note that the long action may delay recovery, plus never sharing pens, needles or syringes, mix-ups, low potassium, allergic reactions and heart failure with thiazolidinediones. Neither is used in a pump, into a vein, or for diabetic ketoacidosis.12
Which, if either, fits is for your prescriber. More detail: Semglee side effects, Lantus side effects, the Semglee and Lantus dosing schedules, the Semglee and Lantus missed-dose pages, how to store Semglee, Basaglar vs Lantus: how do the two insulin glargine brands differ? and Toujeo vs Lantus: how do the two insulin glargine strengths differ?.