ADMELOG (insulin lispro)


Drug overview for ADMELOG (insulin lispro):

Generic name: INSULIN LISPRO (IN-su-lin LIS-proe)
Drug class: Short-Acting Insulins
Therapeutic class: Endocrine

Insulin lispro is a biosynthetic human insulin analog that is prepared using recombinant DNA technology; commercially available insulin lispro products are classified as rapid-acting (insulin lispro, insulin lispro-aabc) or intermediate-acting (insulin lispro protamine). Insulin lispro (Humalog(R)), insulin lispro (Admelog(R)), and insulin lispro-aabc (Lyumjev(R)) are structurally and pharmacologically similar drugs that contain a related substance. Admelog(R) was licensed by the FDA through an abbreviated approval pathway (505(b)(2)) that relied in part on FDA's findings of safety and efficacy for Humalog(R).

Comparative studies found no substantial differences between the pharmacokinetics, immunogenicity, or toxicity of Humalog(R) and Admelog(R). Although Admelog(R) is highly similar to Humalog(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 lispro; thus, biosimilarity to insulin lispro could not be established.

Instead, Admelog(R) was referred to as a ''follow-on'' insulin lispro preparation; FDA determined that there was no need to use a different nonproprietary name (insulin lispro) for Admelog(R) at that time. Subsequently, the classification of insulin was changed to a biologic product, and Admelog(R) was included as a "rollover" drug product under this definition. Insulin lispro-aabc (Lyumjev(R)) was approved under a separate biologics license application with independent studies conducted on the drug.

Admelog(R) and Lyumjev(R) are not considered biosimilar or interchangeable with Humalog(R). In this monograph, unless otherwise stated, the term "insulin lispro products" refers to insulin lispro and insulin lispro-aabc.

No enhanced Uses information available for this drug.
DRUG IMAGES
  • ADMELOG 100 UNIT/ML VIAL
    ADMELOG 100 UNIT/ML VIAL
The following indications for ADMELOG (insulin lispro) have been approved by the FDA:

Indications:
Diabetes mellitus
Type 1 diabetes mellitus
Type 2 diabetes mellitus


Professional Synonyms:
Adult onset diabetes mellitus
Adult onset diabetes
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 mellitus
Juvenile-onset diabetes
Ketosis-prone diabetes mellitus
Ketosis-prone diabetes
Ketosis-prone DM
Ketosis-resistant diabetes mellitus
Ketosis-resistant DM
Maturity onset diabetes mellitus
Maturity onset diabetes
Non-insulin dependent diabetes mellitus
Non-insulin-dependent diabetes mellitus
Type I diabetes mellitus
Type II diabetes mellitus