Semglee(INSULIN GLARGINE-YFGN) (insulin glargine-yfgn)
Last reviewed · Source: First Databank (FDB) drug data
Overview
Insulin glargine, insulin glargine-aglr, and insulin glargine-yfgn are biosynthetic (rDNA origin), long-acting human insulin analogs.
Insulin glargine (Lantus(R) ) and insulin glargine (Basaglar(R) ) are structurally and pharmacologically similar drugs that contain a related drug substance. Basaglar(R) was licensed by FDA through an abbreviated approval pathway (505(b)(2)) that relied in part on FDA's finding of safety and effectiveness for Lantus(R). Comparative studies found no substantial differences between the pharmacokinetics, immunogenicity, or toxicity of Lantus(R) and Basaglar(R).
Although Basaglar(R) is highly similar to Lantus(R) in terms of composition, strength, presentation, structure, and physicochemical and biological properties, it was not approved as a biosimilar or an interchangeable biologic product. At the time of the approval, insulin was classified by FDA as a chemical, not a biologic product, and there was no biologic reference product for insulin glargine; thus, biosimilarity to insulin glargine could not be established. Instead, Basaglar(R) was referred to as a ''follow-on'' insulin glargine preparation; FDA determined that there was no need to use a different nonproprietary name (insulin glargine) for Basaglar(R) at that time.
Subsequently, the classification of insulin was changed to a biologic product, and Basaglar(R) was included as a "rollover" drug product under this definition; however, Basaglar(R) is still not considered a biosimilar or interchangeable with Lantus(R).
Insulin glargine-aglr (Rezvoglar(R)) and insulin glargine-yfgn (Semglee(R)) are biosimilar to insulin glargine (Lantus(R)). FDA defines a biosimilar as a biological product that is highly similar to an FDA-licensed reference biological with the exception of minor differences in clinically inactive components and for which there are no clinically meaningful differences in safety, purity, or potency. The claim of biosimilarity is based on a totality-of-evidence approach, which includes consideration of data from analytical, animal, and clinical studies (e.g., human pharmacokinetic and pharmacodynamic studies, clinical immunogenicity assessment, additional comparative clinical studies).
Therefore, biosimilarity may be established even when there are formulation or minor structural differences as long as these differences are not clinically meaningful. Biosimilars are approved through an abbreviated licensure pathway that establishes biosimilarity between the proposed biological and the reference biological but does not independently establish safety and effectiveness of the proposed biological. In order to be considered an interchangeable biosimilar, a biological product must meet additional requirements beyond demonstrating biosimilarity to its reference product; these requirements include demonstrating that the biological product can be expected to produce the same clinical results as the reference product in any given patient and, for a biological product that is administered more than once to an individual, the risk in terms of safety or diminished efficacy of alternating or switching between use of the biological product and the reference product is no greater than the risk of using the reference product without such alteration or switch.
Biosimilar products that are interchangeable can be substituted for the reference product without the intervention of the healthcare provider who prescribed the reference product. Both insulin glargine-aglr (Rezvoglar(R)) and insulin glargine-yfgn (Semglee(R)) are designated as interchangeable with insulin glargine (Lantus(R)).
In this monograph, unless otherwise stated, the term "insulin glargine products" refers to insulin glargine (the reference drug) and its biosimilars (insulin glargine-aglr and insulin glargine-yfgn).
Insulin glargine is a biosynthetic (rDNA origin), long-acting human insulin analog that is prepared using recombinant DNA technology and a special laboratory strain of nonpathogenic Escherichia coli (K12). Insulin glargine differs structurally from insulin human by the replacement of asparagine at position A21 with glycine and the addition of 2 arginines to the C-terminus of the B-chain. Insulin glargine has pharmacologic effects comparable to those of insulin human.
In clinical studies, the glucose-lowering effect of the 100-unit/mL preparation of insulin glargine was approximately the same as insulin human on a molar basis.
Insulin glargine products are commercially available as an acidic solution with a pH of approximately 4. Neutralization of the acidic insulin glargine solution following injection into subcutaneous tissue results in the formation of microprecipitates of the drug from which small amounts of insulin glargine are slowly released. This results in a relatively constant concentration-time profile over 24-36 hours (dependent upon insulin concentration) with no pronounced peak.
Compared with the 100-unit/mL preparation of insulin glargine, the pharmacokinetic and pharmacodynamic profiles of the 300-unit/mL preparation of insulin glargine demonstrate a less variable response and a longer duration of action (36 versus 24 hours). The absorption of the 300-unit/mL preparation of insulin glargine is more prolonged than that of the 100-unit/mL preparation. Following subcutaneous injection of the 100- or 300-unit/mL preparation of insulin glargine, duration of hypoglycemic action is approximately 24 or 36 hours, respectively.
Duration of action is similar following subcutaneous injection at abdominal, deltoid, or thigh sites. Substantial interindividual and intraindividual variation in duration may occur based on tissue blood supply, temperature, exercise, and/or interindividual and intraindividual differences in response.
In the subcutaneous tissue depot, insulin glargine products are partially metabolized to form 2 metabolites with activity similar to that of insulin. There are no differences in metabolism of insulin glargine products when administered as the 100- or 300-unit/mL preparation. Effect of age, race, body mass index (BMI), and gender on the pharmacokinetics of insulin glargine products has not been evaluated; however, in controlled clinical studies in adult and pediatric patients, subgroup analyses based on age, race, and BMI did not show differences in safety and efficacy between insulin glargine products and isophane (NPH) insulin.
Insulin glargine is commercially available as Lantus(R) (100 units/mL), Basaglar(R) (100 units/mL), and a concentrated preparation (Toujeo(R); 300 units/mL).
Generic name: insulin glargine-yfgn
Pronunciation: (IN-su-lin GLAR-jeen)
Reference product & biosimilars
No reference, biosimilar or interchangeable associated with this drug.
Today’s intelligence on Semglee(INSULIN GLARGINE-YFGN)
Indications
The following indications are listed for Semglee(INSULIN GLARGINE-YFGN):
- Type 1 Diabetes Mellitus
- Type 2 Diabetes Mellitus
Also known as: Adult Onset Diabetes, Adult Onset Diabetes Mellitus, Adult Onset Dm, Diabetes Mellitus Type 1, Diabetes Mellitus Type 2, Diabetes Mellitus Type Ii, Immune Mediated Diabetes Mellitus, Insulin Dependent Diabetes Mellitus, Insulin-Dependent Diabetes Mellitus, Insulin-Dependent Dm, Juvenile Diabetes, Juvenile Onset Dm, Juvenile-Onset Diabetes, Juvenile-Onset Diabetes Mellitus, Ketosis-Prone Diabetes, Ketosis-Prone Diabetes Mellitus, Ketosis-Prone Dm, Ketosis-Resistant Diabetes Mellitus, Ketosis-Resistant Dm, Maturity Onset Diabetes, Maturity Onset Diabetes Mellitus, Non-Insulin Dependent Diabetes Mellitus, Non-Insulin-Dependent Diabetes Mellitus, Type I Diabetes Mellitus, Type Ii Diabetes Mellitus.
Dosing
The dosage of insulin glargine products is expressed in units. Each unit of insulin glargine is approximately equal to 0.036 mg of the drug.
Individualize dosage based on the patient's metabolic needs, blood glucose determinations, and glycemic control goals to obtain optimum therapeutic effect.
Insulin glargine is commercially available as a single-entity preparation in various dosage forms and in fixedcombination with lixisenatide. Consult the prescribing information for additional information on the fixedcombination product.
Insulin glargine products are administered by subcutaneous injection once daily into the abdomen, thigh, or upper arm at the same time each day using a conventional insulin syringe or the appropriate injection pen (e.g., SoloStar(R), KwikPen(R)).
Insulin glargine products should not be administered IV, IM, or via an infusion pump. A planned rotation of sites within an area should be followed to reduce the risk of lipodystrophy and localized cutaneous amyloidosis. Clinical studies have not indicated important differences in absorption of insulin glargine products from the various injection areas (e.g., abdomen, thigh, upper arm). It is not necessary to shake the vials of insulin glargine products prior to measuring the dosage. Insulin glargine products should not be mixed with other insulins, other drugs, or diluted with other solutions.
Insulin glargine products should be inspected visually for particulate matter and discoloration before administration whenever solution and container permit. The drug should be administered only if the solution is clear, colorless, and without particulates.
Unopened injection pens and vials containing insulin glargine products 100 units/mL should be stored at 2-8degreesC and protected from direct heat and light until the expiration date; the drug should not be frozen. Alternatively, unopened injection pens and vials containing insulin glargine products 100 units/mL may be stored at room temperature (below 30degreesC) and away from direct heat and light for up to 28 days. Opened (in-use) vials containing insulin glargine products 100 units/mL should be stored at 2-8degreesC for up to 28 days. Alternatively, such in-use vials may be stored at room temperature away from direct heat and light for up to 28 days. In-use injection pens of insulin glargine products 100 units/mL (e.g., Kwikpen(R), SoloStar(R)) should be stored at room temperature away from heat and direct light for up to 28 days; in-use injection pens should not be refrigerated.
Unopened injection pens of insulin glargine 300 units/mL (Toujeo(R)) should be stored at 2-8degreesC and protected from direct heat and light until the expiration date; the drug should not be frozen. In-use injection pens of insulin glargine 300 units/mL should be stored at room temperature away from heat and direct light for up to 56 days; such in-use injection pens should not be refrigerated.
The accompanying labeling should be consulted for additional details about the administration of insulin glargine products.
No dosing information is available for this tab.
No dosing information is available for this tab.
Drug interactions
There is no enhanced messaging for this drug.
There are no contraindication interactions for this drug.
There are no severe interactions for this drug.
There are no moderate interactions for this drug.
Contraindications
*Known hypersensitivity to insulin glargine or any ingredient in the preparation.
*During episodes of hypoglycemia.
There are no contraindication contraindications for this drug.
There are no severe contraindications for this drug.
There are no moderate contraindications for this drug.
Adverse reactions
Common adverse effects associated with insulin glargine products during clinical trials include hypoglycemia, allergic reactions, injection site reactions, lipodystrophy, pruritus, rash, edema, and weight gain.
There are no severe adverse reactions for this drug.
There are no less severe adverse reactions for this drug.
Precautions
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Safety and efficacy of the 100-unit/mL preparations of insulin glargine products (Lantus(R), Semglee(R), Rezvoglar(R) ) have been established in pediatric patients. Use for this indication is supported by evidence from an adequate and well-controlled study in 174 pediatric patients 6--15 years of age with type 1 diabetes mellitus, and from adequate and well-controlled studies in adults with diabetes mellitus. In the pediatric clinical study, pediatric patients with type 1 diabetes mellitus had a higher incidence of severe symptomatic hypoglycemia compared to adults in studies with type 1 diabetes mellitus.
Safety and efficacy of the 100-unit/mL preparation of insulin glargine (Basaglar(R)) have been established in pediatric patients 6--15 years of age with type 1 diabetes mellitus based on an adequate and well-controlled trial of another insulin glargine product in pediatric patients 6--15 years of age with type 1 diabetes mellitus and additional data in adult patients with type 1 diabetes mellitus. In the pediatric clinical trials, pediatric patients (aged 6--15 years) with type 1 diabetes mellitus had a higher incidence of severe symptomatic hypoglycemia compared to adults in trials with type 1 diabetes mellitus. Safety and efficacy have not been established in children younger than 6 years of age with type 1 diabetes mellitus or in pediatric patients with type 2 diabetes mellitus.
Safety and efficacy of the 300-unit/mL preparation of insulin glargine (Toujeo(R)) have been established in pediatric patients 6 years of age and older with diabetes mellitus. Use for this indication is supported by evidence from an adequate and well-controlled study in 463 pediatric patients 6--17 years of age with type 1 diabetes mellitus and from studies in adults with diabetes mellitus. Safety and efficacy of the 300-unit/mL preparation of insulin glargine (Toujeo(R)) have not been established in children younger than 6 years of age.
Published studies with use of insulin glargine products during pregnancy have not reported a clear association with adverse developmental outcomes including major birth defects, miscarriage, or adverse maternal or fetal outcomes. However, these studies cannot definitely establish the absence of any risk because of methodological limitations including small sample size and some lacking comparator groups. In animal reproduction studies, rats and rabbits were exposed to insulin glargine during organogenesis at 50 and 10 times the human subcutaneous dosage of 0.2 units/kg per day, respectively. Overall, the effects of insulin glargine products did not generally differ from those observed with regular human insulin. However, dilation of the cerebral ventricles was observed in some rabbit fetuses.
There are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy, including increased maternal risk for diabetic ketoacidosis, preeclampsia, spontaneous abortions, preterm delivery, and delivery complications, and increased fetal risk of major birth defects, stillbirth, and macrosomia-related morbidity.
There are either no or limited data on the presence of insulin glargine products in human milk, the effects on the breast-fed infant, or the effects on milk production. Endogenous insulin is present in human milk. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for insulin glargine products, and any potential adverse effects on the breast-fed child from insulin glargine products or from the underlying maternal condition.
In geriatric patients, the initial dosage, dose increments, and maintenance dosage of insulin glargine should be conservative in order to avoid hypoglycemia.
Of the total number of subjects enrolled in clinical studies of patients with type 1 and type 2 diabetes mellitus who were treated with the 100-unit/mL preparation of insulin glargine (Lantus(R)), 316 patients (15%) were >=65 years of age and 42 patients (2%) were >=75 years of age. Of the total number of subjects enrolled in clinical studies of patients with type 2 diabetes who were treated with the 100-unit/mL preparation of insulin glargine (Basaglar(R)) or another insulin glargine product, each in combination with oral agents in a controlled clinical trial environment, 28.3% of patients were >=65 years of age and 4.5% were >=75 years of age. In controlled clinical studies with the 300-unit/mL preparation of insulin glargine (Toujeo(R)), 30 patients (9.8%) with type 1 diabetes mellitus and 327 patients (26.3%) with type 2 diabetes mellitus were >=65 years of age; among them, 2% with type 1 diabetes mellitus and 3% with type 2 diabetes mellitus were >=75 years of age. No overall differences in safety or effectiveness were observed between patients >=65 years of age and younger adult patients; greater sensitivity of some older individuals cannot be ruled out.
Initial dosage, dose increments, and maintenance dosage of insulin glargine should be conservative to avoid hypoglycemia.
ICD codes
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Last reviewed · Source: First Databank (FDB) drug data
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