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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?

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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

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About SEMGLEE

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

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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. 2023. Biocon Biologics Inc. Cambridge, MA.