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.
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.
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.
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 the first interchangeable
biosimilar insulin product, SEMGLEE (insulin glargine-yfgn).
Explore our savings program and learn about selected support organizations that may help you manage your diabetes.
Review step-by-step instructions on how to prepare and use the SEMGLEE prefilled insulin pen.
Please select from the following:
(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.
It is not known if SEMGLEE is safe and effective in children less than 6 years of age with type 1 diabetes.