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Effective November 29, 2022, Viatris completed the sale of substantially all of its biosimilars portfolio (including related product trademarks) to Biocon Biologics Limited and its subsidiaries (“Biocon”) and the relevant marketing authorizations are in process of being transferred. Viatris Inc. and its subsidiaries (“Viatris”) are not affiliates of Biocon but are providing certain transition services to Biocon following the transaction completion date, such as operating websites (including this site) relating to the biosimilars portfolio on Biocon’s behalf.

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(insulin glargine-yfgn) injection

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(insulin glargine-yfgn) injection

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What is an interchangeable biologic product?

According to the FDA, an interchangeable product is a biological product that is approved based on data demonstrating that it is highly similar to an FDA-approved reference product and that there are no clinically meaningful differences between the products.

The interchangeable product can be expected to produce the same clinical result as the reference product in any given patient. Further, if the interchangeable product is administered more than once to a patient, the risk in terms of safety or diminished efficacy from alternating or switching between use of the reference product and interchangeable product is not greater than that from the reference product without such alternation or switch.

Interchangeability of SEMGLEE has been demonstrated for the condition(s) of use, strength(s), dosage form(s), and route(s) of administration described in its Full Prescribing Information.

An interchangeable biologic product may be substituted for the reference product at the pharmacy, depending on state pharmacy laws, without having to consult a physician.

WHAT IS SEMGLEE?

What is Semglee

SEMGLEE is a once-daily long-acting insulin analogue 100 units/mL (U-100) that is FDA-approved as interchangeable with LANTUS in adults and pediatric patients with type 1 diabetes and in adults with type 2 diabetes.
SEMGLEE is not for use to treat diabetic ketoacidosis.

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It is not known if SEMGLEE is safe and effective in children with type 2 diabetes.2

  • T1 Type 1 diabetes in adults and pediatric patients2

  • T2 Type 2 diabetes in adults2

Learn more about SEMGLEE

About Semglee

About SEMGLEE

Learn more about the first interchangeable
biosimilar insulin product, SEMGLEE (insulin glargine-yfgn).

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The semglee Pen

The SEMGLEE Pen

Review step-by-step instructions on how to prepare and use the SEMGLEE prefilled insulin pen.

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References:

  1. FDA News Release. FDA Approves First Interchangeable Biosimilar Insulin Product for Treatment of Diabetes. Available at: https://www.fda.gov/news-events/press-announcements/fda-approves-first-interchangeable-biosimilar-insulin-product-treatment-diabetes
  2. SEMGLEE (insulin glargine-yfgn) injection. Prescribing Information. 2021. Mylan Pharmaceuticals Inc. Morgantown, WV
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Instructions For Use

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SEMGLEE and the Semglee Logo are registered trademarks of Mylan Pharmaceuticals Inc., a Viatris Company.
VIATRIS ADVOCATE and the Viatris Advocate Logo are registered trademarks of Mylan Pharmaceuticals Inc., a Viatris Company.
VIATRIS and the Viatris Logo are trademarks of Mylan Inc., a Viatris Company.
LOYALTYSCRIPT is a trademark of McKesson Corporation.
LANTUS is a registered trademark of Sanofi-Aventis.
© 2022 Viatris Inc. All Rights Reserved.
SEMI-2021-0008 V2

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IMPORTANT SAFETY INFORMATION

(This information also applies to Insulin Glargine (insulin glargine-yfgn) injection)

What is SEMGLEE® (insulin glargine-yfgn) injection 100 Units/mL?

SEMGLEE is a prescription long-acting man-made-insulin used to control high blood sugar in adults and children with type 1 diabetes and in adults with type 2 diabetes.

  • SEMGLEE is not for use to treat diabetic ketoacidosis.

It is not known if SEMGLEE is safe and effective in children less than 6 years of age with type 1 diabetes.

IMPORTANT SAFETY INFORMATION

(This information also applies to Insulin Glargine (insulin glargine-yfgn) injection)

What is SEMGLEE® (insulin glargine-yfgn) injection 100 Units/mL?

SEMGLEE is a prescription long-acting man-made-insulin used to control high blood sugar in adults and children with type 1 diabetes and in adults with type 2 diabetes.

  • SEMGLEE is not for use to treat diabetic ketoacidosis.

It is not known if SEMGLEE is safe and effective in children less than 6 years of age with type 1 diabetes.

IMPORTANT SAFETY INFORMATION

Do not share your pen with other people, even if the needle has been changed. You may give other people a serious infection or get a serious infection from them.

Do not use SEMGLEE during episodes of low blood sugar or if you are allergic to insulin glargine or any of the ingredients in SEMGLEE.

Do not share needles, insulin pens, or syringes with others. Do NOT reuse needles.

Before using SEMGLEE, tell your healthcare provider about all your medical conditions including if you:

  • have liver or kidney problems.
  • take other medicines, especially ones called TZDs (thiazolidinediones).
  • have heart failure or other heart problems. If you have heart failure, it may get worse while you take TZDs with SEMGLEE.
  • are pregnant, planning to become pregnant, or are breastfeeding. It is not known if SEMGLEE may harm your unborn baby or breastfeeding baby.

Tell your healthcare provider about all the medicines you take including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Before you start using SEMGLEE, talk to your healthcare provider about low blood sugar and how to manage it.

Change (rotate) your injection sites within the area you chose with each dose to reduce your risk of getting lipodystrophy (pitted or thickened skin) and localized cutaneous amyloidosis (skin with lumps) at the injection sites. Do not use the same spot for each injection or inject where the skin is pitted, thickened, lumpy, tender, bruised, scaly, hard, scarred or damaged. Tell your doctor if you have any new or worsening symptoms of heart failure, including shortness of breath, swelling of your ankles or feet, sudden weight gain.

SEMGLEE should be taken once a day at the same time every day. Test your blood sugar levels while using insulin, such as SEMGLEE. Do not make any changes to your dose or type of insulin without talking to your healthcare provider. Any change of insulin should be made cautiously and only under medical supervision.

Do NOT dilute or mix SEMGLEE with any other insulin or solution. It will not work as intended and you may lose blood sugar control, which could be serious. SEMGLEE must only be used if the solution is clear and colorless with no particles visible. Always make sure you have the correct insulin before each injection.
While using SEMGLEE, do not drive or operate heavy machinery until you know how SEMGLEE affects you. You should not drink alcohol or use other medicines that contain alcohol.

Other possible side effects may include swelling, weight gain, low potassium levels, injection site reactions, including changes in fat tissue at the injection site, and allergic reactions.

Important Safety Information for SEMGLEE (insulin glargine-yfgn) injection pen

SEMGLEE pen is a disposable single-patient-use prefilled insulin pen. Please talk to your healthcare provider about proper injection technique and follow instructions in the Instruction Leaflet that accompanies the pen.

These are not all the possible side effects of SEMGLEE. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

This summary does not include all the information about SEMGLEE and is not meant to take the place of a discussion with your healthcare provider about your treatment.