the Food and Drug Administration announced June 11.
“Long-acting insulin products like insulin glargine play an important role in the treatment of types 1 and 2 diabetes mellitus,” Patrick Archdeacon, MD, acting associate director for therapeutics in the FDA’s Division of Diabetes, Lipid Disorders, and Obesity, said in a written statement via email.
Semglee will be marketed by Mylan Pharmaceuticals and will be available in a multidose 10-mL vial or a single-patient-use 3-mL prefilled pen.
The approval was based primarily on two randomized, confirmatory clinical trials called INSTRIDE1 and INSTRIDE 2, according to a release by Mylan and Biocon Biologic. They compared Semglee (MYL-1501D) to branded insulin glargine (Lantus) in adults and children for 1 year and found no treatment difference.
The FDA noted that, for patients with type 1 diabetes, Semglee must be used along with a short-acting insulin. The recommended starting dose is approximately one-third of the total daily insulin requirement. For those with type 2 diabetes, the starting dose is 0.2 units/kg or up to 10 units once daily, according to the prescribing information.
Semglee is not recommended for treating diabetic ketoacidosis and is contraindicated during episodes of hypoglycemia.
“Today’s approval provides patients with an additional safe and effective treatment option and also expands the number of products that are available to serve as a reference product for a proposed insulin glargine biosimilar or interchangeable biosimilar product now that the biosimilar pathway is available for insulin products following the statutory transition earlier this year,” Dr. Archdeacon said.