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Semglee FDA Approval History

Last updated by Judith Stewart, BPharm on July 28, 2021.

FDA Approved: Yes (First approved June 11, 2020)
Brand name: Semglee
Generic name: insulin glargine-yfgn
Dosage form: Injection
Company: Mylan Pharmaceuticals Inc.
Treatment for: Diabetes, Type 1, Diabetes, Type 2

Semglee (insulin glargine-yfgn) is a long-acting human insulin analog biosimilar to Lantus (insulin glargine) indicated to improve glycemic control in adults and pediatric patients with type 1 diabetes mellitus, and adults with type 2 diabetes mellitus.

  • Semglee was first approved in June 2020 as an equivalent to Lantus under the 505(b)(2) NDA pathway, meaning it could be prescribed for the same indications as Lantus, but was not considered a biosimilar, and was not interchangeable.
  • On July 28, 2021, the FDA granted approval for the biologics license application (BLA) for Semglee, making it the first interchangeable biosimilar insulin product approved in the U.S.
  • Semglee (insulin glargine-yfgn) is now both biosimilar to, and interchangeable with (can be substituted for), its reference product Lantus (insulin glargine).
  • Semglee 100 units/mL (U-100) injection is supplied as 10 mL multiple-dose vials and 3 mL single-patient-use prefilled pens.
  • Semglee is administered subcutaneously into the abdominal area, thigh, buttocks or upper arms once daily.
  • Common side effects include hypoglycemia, allergic reactions, injection site reactions, lipodystrophy, pruritus, rash, edema and weight gain.

Development timeline for Semglee

Jul 28, 2021Approval FDA Approves Semglee (insulin glargine-yfgn) as the First Interchangeable Biosimilar Insulin Product for Treatment of Diabetes
Jun 11, 2020Approval FDA Approves Semglee (insulin glargine injection) for Type 1 and Type 2 Diabetes

Further information

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