The first FDA-approved, interchangeable insulin glargine

Switch your adult and pediatric patients with Type 1 diabetes and your adult patients with Type 2 diabetes patients from LANTUS^® to SEMGLEE or Insulin Glargine (insulin glargine-yfgn) injection, the first FDA-approved, interchangeable biosimilar insulin glargine.

Indicated to improve glycemic control in adults and pediatric patients from 6 years old with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus.

Limitations of use: SEMGLEE is not recommended for the treatment of diabetic ketoacidosis.

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

• SEMGLEE is a once-daily long-acting insulin analog (100 units/ml) that is FDA-approved as interchangeable for LANTUS in adults and pediatric patients with type 1 diabetes and in adults with type 2 diabetes.
• SEMGLEE offers highly similar clinical benefits compared with LANTUS including duration of action, rate of hypoglycemia and effect on changes HbA1c and fasting plasma glucose from baseline when used as directed.
• SEMGLEE is biosimilar to, and depending on state pharmacy laws, can be substituted for, its reference product LANTUS, a long-acting insulin analog.
• SEMGLEE is available as a solution for injection in 10ml multiple dose vials or in 3ml single-patient-use prefilled injector pens.

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 is a biosimilar that meets additional requirements and may be substituted for the reference product at the pharmacy, depending on state pharmacy laws.

SEMGLEE (insulin glargine-yfgn) injection is a sterile solution for subcutaneous use. Insulin glargine is a recombinant human long-acting insulin analog. The primary activity of insulin, including SEMGLEE, is regulation of glucose metabolism. Insulin and its analogs lower blood glucose by stimulating peripheral glucose uptake, especially by skeletal muscle and fat, and by inhibiting hepatic glucose production. Insulin inhibits lipolysis and proteolysis and enhances protein synthesis. Insulin glargine is metabolized into 2 active metabolites M1 and M2.

The pharmacodynamic profile for SEMGLEE was determined after subcutaneous administration of a single 0.5 U/kg dose in a euglycemic clamp study conducted in 116 type 1 diabetes patients.

The median time to maximum effect of SEMGLEE (measured by the peak rate of glucose infusion) was approximately 11.3 hours. The pharmacodynamic profile of SEMGLEE following subcutaneous injection demonstrated sustained glucose lowering activity over 24 hours with no pronounced peak. The arithmetic mean area under the glucose infusion rate curves (AUC GIR 0-24h) and maximum glucose infusion rate were 1423 mg/kg and 1.8 mg/kg/min, respectively. 

The time course of action of insulin may vary considerably in different individuals or within the same individual.

Absorption
After subcutaneous injection of a single 0.5 U/kg dose of SEMGLEE in a euglycemic clamp study conducted in 116 type 1 diabetes patients, the M1 active metabolite plasma concentration profile indicated a prolonged absorption and a relatively constant concentration/time profile over 24 hours.
The median time to maximum M1 plasma concentration was 12 hours after injection. The mean plasma observed area under the concentration-time curve for M1 from time zero to 24 hours and peak plasma concentration were 10.5 ng*hr/mL and 0.64 ng/mL, respectively.

Elimination
A metabolism study in humans indicates that insulin glargine is partly metabolized at the carboxyl terminus of the B chain in the subcutaneous depot to form two active metabolites with in vitro activity similar to that of human insulin, M1 (21^A-Gly-insulin) and M2 (21^A-Gly-des30^B-Thr-insulin). Unchanged drug and these degradation products are also present in the circulation.

Specific Population
Age, Race, and Gender
Effect of age, race, and gender on the pharmacokinetics of SEMGLEE has not been evaluated.

Obesity
Effect of Body Mass Index (BMI) on the pharmacokinetics of SEMGLEE has not been evaluated.

• SEMGLEE^® (insulin glargine-yfgn) injection. Prescribing Information. 2023. Biocon Biologics Inc. Cambridge, MA.