Truvelog
Sponsor
ARTGs
325474, 325475
325474, 325475
Device/Product name
Truvelog
Active Ingredient
Insulin aspart
Date of decision
Published
Submission type
New biosimilar medicine
ATC codes
A10AB05
Decision
Approved
What was the decision based on
The decision was based on quality (chemistry and manufacturing), nonclinical (pharmacology and toxicology), clinical (pharmacology, safety and efficacy) and risk management plan information submitted by the sponsor. The benefit-risk profile of Truvelog was considered favourable for the therapeutic use approved.
What steps were involved in the decision process
Registration timeline
The following table summarises the key steps and dates for this application.
| Description | Date |
|---|---|
| Submission dossier accepted and first round evaluation commenced | 2 December 2019 |
| First round evaluation completed | 30 April 2020 |
| Sponsor provides responses on questions raised in first round evaluation | 26 June 2020 |
| Second round evaluation completed | 5 August 2020 |
| Delegate's overall benefit-risk assessment and request for Advisory Committee advice | 9 September 2020 |
| Sponsor's pre-Advisory Committee response | Not applicable |
| Advisory Committee meeting | Not applicable |
| Registration decision (Outcome) | 14 October 2020 |
| Completion of administrative activities and registration on ARTG | 15 October 2020 |
| Number of working days from submission dossier acceptance to registration decision* | 170 |
*Statutory timeframe for standard applications is 255 working days
Date of entry onto ARTG
Original publication date
Black triangle scheme
No
Dose forms
Solution for injection
Strength
100 units/mL
Other ingredients
Phenol, metacresol, zinc chloride, polysorbate 20, sodium chloride, hydrochloric acid (for pH adjustment), sodium hydroxide (for pH adjustment), water for injections
Containers
Cartridge and pre-filled pen
Pack sizes
1, 5 or 10 pre-filled pens5 or 10 cartridges
Routes of administration
Subcutaneous injection
Dosage
Insulin aspart has a faster onset and a shorter duration of action than soluble human insulin. Due to the faster onset of action, insulin aspart should generally be given immediately before a meal or when necessary, soon after the start of a meal.
The dosage of insulin aspart is determined by the physician according to the patient's individual needs. The individual insulin requirement is usually between 0.5 and 1.0 units/kg/day in adults and children. In a meal related treatment 50 to 70% of this requirement may be provided by Truvelog and the remainder provided by an intermediate-acting or long-acting insulin given at least once a day.
For further information refer to the Product Information.
Pregnancy category
ADrugs which have been taken by a large number of pregnant women and women of childbearing age without any proven increase in the frequency of malformations or other direct or indirect harmful effects on the fetus having been observed.The use of any medicine during pregnancy requires careful consideration of both risks and benefits by the treating health professional. This must not be used as the sole basis of decision making in the use of medicines during pregnancy. The TGA does not provide advice on the use of medicines in pregnancy for specific cases. More information is available from obstetric drug information services in your State or Territory.
What was approved
Truvelog (insulin aspart) was approved for the following therapeutic use:
Treatment of diabetes mellitus.
What is this medicine and how does it work
Truvelog (insulin aspart) is a biosimilar medicine to NovoRapid Penfill and NovoRapid FlexPen.Insulin lowers blood glucose levels by binding to insulin receptors to increase glucose uptake and inhibit hepatic glucose output. As with all insulins in clinical practice, the duration of action of insulin aspart will vary according to the dose, injection site, blood flow, temperature and level of physical activity.Insulin aspart is equipotent to soluble human insulin on a molar basis. Insulin aspart produces a more rapid and pronounced blood glucose lowering effect than soluble human insulin, due to the faster onset of action. Insulin aspart has a shorter duration of action compared to soluble human insulin after subcutaneous injection. When administered immediately before a meal, the effect of insulin aspart more closely mimics normal physiological postprandial insulin release than soluble human insulin.The onset of action of insulin aspart occurs within 10 to 20 minutes of subcutaneous injection. The maximum effect is exerted between 1 and 3 hours after injection. The duration of action is 3 to 5 hours. Insulin aspart has a more predictable time to peak effect within subjects than soluble human insulin.
What post-market commitments will the sponsor undertake
- This approval does not impose any requirement for the submission of Periodic Safety Update reports. It should be noted that it is a requirement that all existing requirements for the submission of PSURs as a consequence of the initial registration or subsequent changes must be completed.
- The Consumer Medicines Information (CMI) and Instructions for Use (IFU) leaflet must be included with the products as package insert. The CMI should have a link to the full version of the Product Information (PI) on the TGA website.
- Laboratory testing and compliance with Certified Product Details (CPD)
- All batches of Truvelog supplied in Australia must comply with the product details and specifications approved during evaluation and detailed in the CPD.
- When requested by the TGA, the sponsor should be prepared to provide product samples, specified reference materials and documentary evidence to enable the TGA to conduct laboratory testing on the Products. Outcomes of laboratory testing are published biannually in the TGA Database of Laboratory Testing Results and periodically in testing reports on the TGA website.