SEMGLEE® (insulin glargine-yfgn) injection Home

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

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
CHANGE IN A1c

There were no statistically significant differences in A1c profiles between treatment groups observed over time.³
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.
SAFETY

Rates of treatment-emergent adverse events (TEAEs) were similar between the SEMGLEE and Lantus groups at Week 52.³

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
CHANGE IN A1c

There were no statistically significant differences in A1c profiles between treatment groups observed over time.⁴
SAFETY

Rates of treatment-emergent adverse events (TEAEs) were similar between the SEMGLEE and Lantus groups at Week 24.⁴

STUDY DESIGN

Eligible participants from INSTRIDE 1 who completed 52 weeks of Lantus treatment were randomized 1:1 to the Lantus sequence (n=63; Lantus for 36 weeks) or to the treatment-switching sequence (n=64; SEMGLEE [Weeks 0-12], Lantus [Weeks 12-24] and SEMGLEE [Weeks 24-36]).²
CHANGE IN A1c

The study met its primary objective by demonstrating that the change in A1c from baseline to Week 36 in the SEMGLEE treatment sequence was equivalent to the change in the Lantus treatment sequence.²
SAFETY

Rates of treatment-emergent adverse events (TEAEs) were similar between the SEMGLEE and Lantus sequence groups during the 36 week 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 52 weeks: 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 24 weeks: 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.