BASAGLAR KWIKPEN U-100 (insulin glargine,human recombinant analog)

Drug overview for BASAGLAR KWIKPEN U-100 (insulin glargine,human recombinant analog):

Generic name: INSULIN GLARGINE,HUMAN RECOMBINANT ANALOG (IN-su-lin GLAR-jeen)
Drug class: Intermediate-, Long-acting, and Combination Insulins
Therapeutic class: Endocrine

Insulin glargine is a biosynthetic (rDNA origin), long-acting human insulin analog.

Insulin glargine is commercially available as Lantus(R) (100 units/mL), a ''follow-on'' preparation (Basaglar(R); 100 units/mL), and a concentrated preparation (Toujeo(R); 300 units/mL). Lantus(R) and Basaglar(R) are structurally and pharmacologically similar drugs that contain a related drug substance. Basaglar(R) was licensed by the US Food and Drug Administration (FDA) through an abbreviated approval pathway (505(b)(2)) that relies in part on FDA's finding of safety and effectiveness for Lantus(R).

Comparative studies have 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. Insulin is classified by FDA as a chemical, not a biologic product, so there is no biologic reference product for insulin glargine; thus, biosimilarity to insulin glargine cannot be established. Instead, Basaglar(R) is 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 this time.