NOVOLOG PENFILL (insulin aspart)


Drug overview for NOVOLOG PENFILL (insulin aspart):

Generic name: INSULIN ASPART (IN-su-lin AS-part)
Drug class: Short-Acting Insulins
Therapeutic class: Endocrine

Insulin aspart, insulin aspart-szjj, and insulin aspart-xjhz are biosynthetic, rapid-acting human insulin analogs that are prepared using recombinant DNA technology. Insulin aspart-xjhz (Kirsty(R)) and insulin aspart-szjj (Merilog(R)) are biosimilar to insulin aspart (Novolog(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 alternation 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. Insulin aspart-xjhz (Kirsty(R)) is designated as interchangeable with insulin aspart. In this monograph, unless otherwise stated, the term "insulin aspart products" refers to insulin aspart (the reference drug) and its biosimilars (insulin aspart-xjhz and insulin aspart-szjj).

Insulin aspart is commercially available as Novolog(R) (100 units/mL) and Fiasp(R) (100 units/mL) and in fixed combination with insulin aspart protamine (Novolog(R) Mix 70/30; 100 units/mL with 30% as insulin aspart and 70% as insulin aspart protamine). Two insulin aspart biosimilars are currently available. Biosimilarity of these products has been demonstrated for the indications described in Table 1. Table 1. Insulin Aspart Biosimilar Products and FDA-licensed Indications FDA Labeled Indication Type 1 Diabetes Mellitus Type 2 Diabetes Mellitus Insulin aspart-szjj X X Insulin aspart-xjhz X X
DRUG IMAGES
  • NOVOLOG PENFILL 100 UNIT/ML
    NOVOLOG PENFILL 100 UNIT/ML
The following indications for NOVOLOG PENFILL (insulin aspart) 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