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SEMGLEE®
(insulin glargine-yfgn)
is interchangeable
with Lantus®.1 But what sets it apart is
the company behind it.
BIOCON BIOLOGICS IS FIGHTING FOR EVERYONE WHO NEEDS INSULIN
LOWERING THE COST
by leading the industry toward more affordable insulin options2
EXPANDING ACCESS IN THE US
with the launch of the first interchangeable biosimilar1
DELIVERING TO THOSE WHO NEED IT
supplying 5.25 billion doses of insulin globally to patients since 20043
EVERYTHING WE STAND FOR IS RIGHT HERE
A long-acting insulin biosimilar interchangeable with Lantus1,4,5
Similar efficacy, immunogenicity, and safety profiles1,4,5
Similar prefilled pen with no dosing differences1,4,5
ONE BIOSIMILAR, TWO WAYS
Prescribe branded SEMGLEE or unbranded Insulin Glargine-yfgn injection for your appropriate patients.
To increase affordable access and availability for patients with diabetes, we made 2 versions of our product: a branded version, SEMGLEE (insulin glargine-yfgn) injection, and an unbranded version, Insulin Glargine-yfgn injection. Both products offer the same high-quality insulin and can be safely substituted for Lantus.1,6
THE UNBRANDED VERSION OF SEMGLEE IS IDENTICAL TO SEMGLEE1,6
SAME active ingredients
SAME inactive ingredients
SAME quality control parameters
SAME manufacturing process
SAME delivery device
SAME raw material sourcing
When you give your patients the unbranded version of SEMGLEE, you give them the same exact medication as SEMGLEE.1,6
RELIABLE PATIENT SUPPORT
Savings Card Program*
- Eligible commercially insured patients may pay as little as $0 up to $94 per 30-day prescription. Savings may vary depending upon your patient's out-of-pocket costs
- For questions regarding the SEMGLEE and Insulin Glargine-yfgn injection Savings Card Program, call 1-800-657-7613 Monday-Friday 8 AM-8 PM ET
Trial Voucher Program†
The Trial Voucher Program offers eligible patients a voucher for a free trial of 5 pens or 2 vials of either insulin product.
- Voucher must be requested by a healthcare professional
- A valid prescription must accompany the voucher
Urgent Need State Insulin Program‡
The Urgent Need State Insulin Program allows eligible patients who are in urgent need of insulin to receive a one-time, 30-day supply of SEMGLEE or Insulin Glargine-yfgn injection at their pharmacy. Voucher must be requested by a pharmacist.
‡Eligibility and restrictions apply as required by the applicable State Insulin Affordability/Safety Net Program law.FRIENDLY INJECTION ASSISTANCE
There's a lot for patients to learn about injecting any insulin. But SEMGLEE has got your back. Our informative injection video walks patients through every step of the process—so they can learn on their own time, at their own pace.
ROBUST BIOSIMILARITY DATA
SEMGLEE clinical efficacy and switch studies
- In randomized, open-label, Phase 3 trials conducted in patients with type 1 and type 2 diabetes, SEMGLEE and Lantus demonstrated highly similar results regarding changes in A1c and FPG from baseline7,8
- An additional study showed that switching patients between SEMGLEE and Lantus resulted in equivalent efficacy and comparable safety compared to patients receiving only Lantus9
All insulin companies are not the same.
LOOK FOR THE ONE WHO,S BEEN STANDING WITH YOU ALL ALONG
Learn more about our global work in insulin here. 
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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. Joshi SR, Mittra S, Raj P, Suvarna VR, Athalye SN. Biosimilars and interchangeable biosimilars: facts every prescriber, payor, and patient should know—insulins perspective. Expert Opin Biol Ther. 2023;23(8):693-704. 3. Biocon Biologics. Strategic Action. Transformational Growth: Integrated Annual Report FY 2023. Biocon Biologics Limited. Accessed March 18, 2024. https://www.biocon.com/docs/BBL_Integrated_Annual_Report_FY2023_Aug08.pdf 4. SEMGLEE. Prescribing information. Biocon Biologics Inc; 2023. 5. LANTUS. Prescribing information. sanofi-aventis U.S. LLC; 2023. 6. Insulin Glargine-yfgn. Prescribing information. Biocon Biologics Inc; 2023. 7. 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. 8. 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. 9. 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.
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.