Semglee is an insulin glargine “biosimilar” approved for diabetes in the US. A biosimilar is a biological product that is highly similar to and has no clinically meaningful differences from an existing FDA-approved reference product. Semglee is a once-daily basal insulin indicated to improve glycemic control in type 1 and type 2 diabetes. Semglee is a cost-effective, long-acting insulin option.
Studies comparing Semglee to Lantus (branded insulin glargine):
INSTRIDE1: 52 week open-label, randomized trial that tested the efficacy and safety of once daily Semglee injections administered with mealtime insulin lispro in type 1 diabetics. One of the outcomes of interest was change in HbA1C from baseline to week 24. Mean HbA1C change at week 24 was 0.14% for Semglee and 0.11 % for reference insulin glargine (Lantus). The safety profiles were similar between both insulins. [1]
INSTRIDE2: 24 week, multi-centered, open-label, randomized, non-inferiority study that compared the safety and efficacy of Semglee with Lantus in Type 2 diabetics that were insulin-naïve and on oral antidiabetic agents. Again, the change in HbA1C was measured at baseline to week 24. Mean change in HbA1C from baseline at week 24 was -0.60% for Semglee and -0.66% for Lantus. Safety and tolerability were similar between the insulins. This trial demonstrated the non-inferiority of Semglee to Lantus. [2]
Dosing [3]
Type 1 Diabetes
The recommended starting dose of SEMGLEE in patients with type 1 diabetes should be approximately one-third of the total daily insulin requirements. Short-acting, premeal insulin should be used to satisfy the remainder of the daily insulin requirements.
Type 2 Diabetes
The recommended starting dose of SEMGLEE in patients with type 2 diabetes who are not currently treated with insulin is 0.2 units/kg or up to 10 units once daily. One may need to adjust the amount and timing of short-or rapid-acting insulins and dosages of other antidiabetic drugs.
• Note: the dose remains the same when converting between Lantus, Basaglar, and Semglee.
Storage
Semglee is available as a 10 mL multi-dose vial and 3 mL single-patient-use prefilled pen.
10 ml vial
Store unused vials under refrigeration between 36 and 46 F. Once opened, the vial may be stored in the refrigerator or at room temperature up to 86 F. Throw vials away 28 days from opening.
3 mL single patient use pen
The pen is pre-filled with 3 ml solution containing 100 U/ml insulin glargine. The pen can deliver up to 80 insulin units with a single injection. Needles for the pen are prescribed separately. Storage of opened pens: Once in use, store pens at room temperature (up to 86 degrees F [30 degrees C]) for up to 28 days; do NOT refrigerate. Once removed from refrigeration, pens should be discarded after 28 days, even if they have not been opened and even if they still contain insulin.
Prescribing
Semglee is not yet an AB rated generic medication, therefore the prescriber must write for Semglee or insulin glargine. The manufacturer of Semglee is seeking interchangeable status.
References
- Blevins TC, Barve A, Sun B, Ankersen M. Efficacy and safety of MYL-1501D vs insulin glargine in patients with type 1 diabetes after 52weeks: Results of the INSTRIDE 1 phase III study. Diabetes Obes Metab. 2018;20(8):1944-1950.
- Blevins TC, Barve A, Sun B, et al. Efficacy and safety of MYL-1501D versus insulin glargine in patients with type 2 diabetes after 24 weeks: Results of the phase III INSTRIDE 2 study. Diabetes Obes Metab. 2019;21(1):129-135.
- SEMGLEE™ (insulin glargine injection). Prescribing Information. 2020. Mylan Pharmaceuticals Inc. Morgantown, WV.
