For UK healthcare professionals only.

This formulary decision guide was developed from content provided by Sanofi Ltd in a format developed by Guidelines in Practice.

Key points

  • Trurapi is indicated for the treatment of diabetes mellitus in adults, adolescents, and children aged 1 year and above1
  • In a head-to-head study involving patients with type 1 diabetes mellitus (T1DM), Trurapi demonstrated similar pharmacokinetic exposure profiles and glucodynamic potency to the originator product, NovoRapid2
  • In a head-to-head study involving patients with T1DM and type 2 diabetes mellitus (T2DM), similar efficacy and safety results were observed for the biosimilar, Trurapi, and the originator product, NovoRapid3
  • Trurapi is available in the SoloSTAR® pen, the most prescribed disposable insulin pen wordwide4
  • Trurapi NHS list price is 30% less than the originator for pre-filled pens and the cartridges.5

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Product name

Trurapi®(insulin aspart 100 units/ml)

▼This medicine is subject to additional monitoring. This will allow quick identification of new safety information.

Indications

  • Trurapi is indicated for the treatment of diabetes mellitus in adults, adolescents, and children aged 1 year and above.1

Dosage

  • The dose of Trurapi is individual and determined in accordance with the needs of the patient1
  • Trurapi should normally be used in combination with intermediate-acting or long-acting insulin1
  • Blood glucose monitoring and insulin dose adjustments are recommended to achieve optimal glycaemic control1
  • The individual insulin requirement in adults and children is usually between 0.5 and 1.0 unit/kg/day—in a basal-bolus treatment regimen 50%–70% of this requirement may be provided by Trurapi and the remainder by intermediate-acting or long-acting insulin1
  • Adjustment of dose may be necessary if patients undertake increased physical activity, change their usual diet, or during concomitant illness.1

Similarity

  • Similar pharmacokinetic (PK) and pharmacodynamic (PD) profiles have been demonstrated between Trurapi and the originator product (NovoRapid)2
  • A head-to-head study in patients with type 1 (T1DM) and type 2 diabetes mellitus (T2DM) demonstrated similar efficacy, tolerability, and safety profile for Trurapi and the originator3
  • No dose conversion is necessary due to 1:1 dosing between Trurapi and the originator3
  • When transferring from other insulin medicinal products, adjustment of the Trurapi dose and the dose of the basal insulin may be necessary; Trurapi has a faster onset and a shorter duration of action than soluble human insulin
  • Close glucose monitoring is recommended during the transfer and in the initial weeks thereafter. 

Efficacy

  • In 597 patients with T1DM or T2DM treated for 26 weeks, there was similar glycaemic control between Trurapi and the originator regarding:3
    • reduction in HbA1c from baseline (least square [LS] mean difference Trurapi vs. NovoRapid: 0.08% [95%CI -0.192–0.039])
    • change in fasting blood glucose from baseline to week 26 (-0.49 mmol/l Trurapi vs -0.17 mmol/l NovoRapid)
    • proportion of patients achieving HbA1c target of <7% at week 26 (16.6% Trurapi vs. 14.5% NovoRapid)
    • change in self-measured plasma glucose, including postprandial glucose excursions.

Safety profile

  • In 597 patients with T1DM or T2DM treated for 26 weeks, there was similar glycaemic control between Trurapi and the originator regarding:3
    • the percentage of patients with at least one episode of hypoglycaemia (regardless of category) during the 26-week treatment period
    • the proportion of patients reporting severe hypoglycaemia (4.0% Trurapi vs. 3.4% NovoRapid)
    • the percentage of patients reporting any treatment-emergent adverse event (TEAE) (51.8% Trurapi vs. 49.3% NovoRapid) or serious TEAE (8.3% Trurapi vs. 6.1% NovoRapid)
    • the incidence and prevalence of anti-insulin aspart antibodies.

Device

  • Trurapi is available in the SoloSTAR® pen, the most prescribed disposable insulin pen wordwide4
  • Trurapi will be available to be prescribed in prefilled SoloStar pens and cartridges to be used in the AllStar and Junior Star insulin pens from mid July 2021.

Savings to the NHS

  • NHS England’s targets for the adoption of best-value biologics are:6
    • 90% of new patients starting on the best-value biologic (including biosimilars) within 3 months of guidance becoming available
    • 80% of applicable existing patients switched to the best-value biologic within 12 months
  • Trurapi NHS list price is 30% less than the originator for pre-filled pens and the cartridges.5

References

  1. Sanofi. Insulin aspart Sanofi 100 units/ml solution for injection in cartridge—summary of product characteristics. April 2021. 
  2. Kapitza C, et al. Diabetes Technol Ther 2020; 22 (4); 278–284.
  3. Garg S et al. Diabetes Technol Ther 2020; 22 (2): 85–95.
  4. Data on file - IQVIA Worldwide Disposable Insulin Pen Usage in 2020, MAT-GB-2101762(v1.0).
  5. Data on File, MAT-GB-2101599 April 2021 
  6. PharmaPhorum. Breaking policies and perceptual barriers: biosimilars. Available at: https://deep-dive.pharmaphorum.com/magazine/market-access-2020/breaking-policy-and-perceptual-barriers-biosimilars/ (accessed May 2021)

MAT-GB-2101070(v2.0)

Date of preparation: July 2021