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The proven biosimilarity is right in front of you
SEMGLEE® meets the rigorous approval standards of the Food & Drug Administration (FDA) for biosimilars and their additional benchmark for interchangeability.1 So your patients can be switched between SEMGLEE and Lantus®, with no clinically meaningful differences in effectiveness and no increased safety risk.2
INSTRIDE 1
In the INSTRIDE 1 clinical trial, SEMGLEE demonstrated noninferiority to Lantus in patients with type 1 diabetes.3
Click below to expand and view the evidence, and see for yourself.
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STUDY DESIGN
INSTRIDE 1 was a multicenter, open-label, randomized, parallel-group, Phase 3, 52-week noninferiority study comparing the efficacy, safety, and immunogenicity of SEMGLEE to those of Lantus when added to mealtime insulin for 558 adults (18-65 years) with type 1 diabetes.3
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CHANGE IN A1c
There were no statistically significant differences in A1c profiles between treatment groups observed over time.3
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CHANGE IN FPG
No statistically significant differences were observed in change from baseline in FPG between the 2 treatment groups at Weeks 12, 36, and 52.3
FPG=fasting plasma glucose.
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SAFETY
Rates of treatment-emergent adverse events (TEAEs) were similar between the SEMGLEE and Lantus groups at
INSTRIDE 2
In the INSTRIDE 2 study, SEMGLEE demonstrated noninferiority to Lantus in patients with type 2 diabetes in combination with oral antidiabetic drugs (OADs).4
Click below to expand and view the evidence, and see for yourself.
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STUDY DESIGN
INSTRIDE 2 was a multicenter, open-label, randomized, parallel-group, Phase 3, 24-week noninferiority study comparing efficacy and safety of SEMGLEE with those of Lantus when taken in combination with OADs in 560 insulin-naïve and insulin–non-naïve patients (18-65 years) with type 2 diabetes.4
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CHANGE IN A1c
There were no statistically significant differences in A1c profiles between treatment groups observed over time.4
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SAFETY
Rates of treatment-emergent adverse events (TEAEs) were similar between the SEMGLEE and Lantus groups at
INSTRIDE 3
INSTRIDE 3 shows that switching patients between SEMGLEE and Lantus resulted in equivalent efficacy, safety, and immunogenicity.2
Click below to expand and view the evidence, and see for yourself.
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STUDY DESIGN
Eligible participants from INSTRIDE 1 who completed of Lantus treatment were randomized 1:1 to the Lantus sequence (n=63; Lantus for ) or to the treatment-switching sequence (n=64; SEMGLEE [Weeks 0-12], Lantus [Weeks 12-24] and SEMGLEE [Weeks 24-36]).2
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CHANGE IN A1c
The study met its primary objective by demonstrating that the change in A1c from baseline to in the SEMGLEE treatment sequence was equivalent to the change in the Lantus treatment sequence.2
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SAFETY
Rates of treatment-emergent adverse events (TEAEs) were similar between the SEMGLEE and Lantus sequence groups during the treatment period.2
References
1. FDA approves first interchangeable biosimilar insulin product for treatment of diabetes. FDA News Release. July 28, 2021. Accessed February 7, 2024. https://www.fda.gov/news-events/press-announcements/fda-approves-first-interchangeable-biosimilar-insulin-product-treatment-diabetes 2. Blevins TC, Barve A, Raiter Y, et al. Efficacy and safety of MYL-1501D versus insulin glargine in people with type 1 diabetes mellitus: results of the INSTRIDE 3 phase 3 switch study. Diabetes Obes Metab. 2020;22(3):365-372. 3. Blevins TC, Barve A, Sun B, Ankersen M. Efficacy and safety of MYL-1501D vs insulin glargine in patients with type 1 diabetes after results of the INSTRIDE 1 phase III study. Diabetes Obes Metab. 2018;20(8):1944-1950. 4. Blevins TC, Barve A, Sun B, et al. Efficacy and safety of MYL-1501D versus insulin glargine in patients with type 2 diabetes after results of the phase III INSTRIDE 2 study. Diabetes Obes Metab. 2019;21(1):129-135.
IMPORTANT SAFETY INFORMATION AND INDICATIONS
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
SEMGLEE is contraindicated during episodes of hypoglycemia and in patients with hypersensitivity to insulin glargine products or any of the excipients in SEMGLEE.
WARNINGS AND PRECAUTIONS
Insulin pens, needles, or syringes must never be shared between patients. Do NOT reuse needles.
Monitor blood glucose in all patients treated with insulin. Changes in an insulin regimen (e.g., insulin strength, manufacturer, type, injection site or method of administration) may affect glycemic control and predispose to hypoglycemia or hyperglycemia. Make any changes to a patient’s insulin regimen under close medical supervision with increased frequency of blood glucose monitoring.
Repeated insulin injections into areas of lipodystrophy or localized cutaneous amyloidosis have been reported to result in hyperglycemia; and a sudden change in the injection site (to an unaffected area) has been reported to result in hypoglycemia. Advise patients to rotate the injection site to unaffected areas and closely monitor for hypoglycemia.
Hypoglycemia is the most common adverse reaction associated with insulins, including insulin glargine products. Severe hypoglycemia can cause seizures, may be life threatening, or cause death. Hypoglycemia can impair concentration and reaction time.
Accidental mix-ups between insulin products have been reported. To avoid medication errors between SEMGLEE and other insulins, instruct patients to always check the insulin label before each injection.
Severe, life-threatening, generalized allergy, including anaphylaxis, can occur. Discontinue SEMGLEE, treat and monitor until symptoms and signs resolve.
All insulin products, including SEMGLEE, cause a shift in potassium from the extracellular to intracellular space, possibly leading to hypokalemia. Untreated hypokalemia may cause respiratory paralysis, ventricular arrhythmia, and death. Monitor potassium levels in patients at risk for hypokalemia, if indicated.
Fluid retention, which may lead to or exacerbate heart failure can occur with concomitant use of thiazolidinediones (TZDs) with insulin. These patients should be observed for signs and symptoms of heart failure. If heart failure develops, dosage reduction or discontinuation of the TZD must be considered.
Do not dilute or mix SEMGLEE with any other insulin or solution. If mixed or diluted, the solution may become cloudy, and the onset of action/time to peak effect may be altered in an unpredictable manner. Do not administer SEMGLEE via an insulin pump or intravenously because hypoglycemia can occur.
A reduction in the SEMGLEE dose may be required in patients with renal or hepatic impairment.
ADVERSE REACTIONS
Adverse reactions commonly associated with insulin glargine products include hypoglycemia, allergic reactions, injection site reactions, lipodystrophy, pruritis, rash, edema, and weight gain.
DRUG INTERACTIONS
Certain drugs may affect glucose metabolism, requiring insulin dose adjustment and close monitoring of blood glucose. The signs of hypoglycemia may be reduced in patients taking anti-adrenergic drugs (e.g., beta-blockers, clonidine, guanethidine, and reserpine).
To report SUSPECTED ADVERSE REACTIONS, contact Biocon Biologics at 1-833-986-1468 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
INDICATIONS AND USAGE
SEMGLEE (insulin glargine-yfgn) injection is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus.
Limitations of Use
SEMGLEE is not recommended for the treatment of diabetic ketoacidosis.
Please see Full Prescribing Information for SEMGLEE.