Information intended for healthcare professionals only.

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

View prescribing information here

Key points

FDG-Semglee (insulin glargine biosimilar)

  • Comparative pharmacokinetic and pharmacodynamic studies have demonstrated the bioequivalence of MYL-1501D (Semglee®) to both US and European insulin glargine in patients with type 1 diabetes mellitus (T1DM)1
  • Semglee has been demonstrated to have equivalent efficacy to Lantus® in the treatment of hyperglycaemia in naive and existing patients with T1DM and type 2 diabetes mellitus (T2DM) taking reference insulin glargine2,3
  • The Semglee pen is based on the comparable insulin delivery pen, the Lantus® SoloStar® *, in size and function
  • Semglee NHS list price is >20% lower than the reference product.4

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Drug name

Semglee®▼ (insulin glargine biosimilar)
100 units/ml solution for injection in pre-filled pen

Indications

  • Treatment of diabetes mellitus in adults, adolescents, and children aged 2 years and above.5

Dosage

  • Semglee should be administered once daily at any time, but at the same time each day5
  • The pre-filled pen delivers insulin in increments of 1 unit up to a maximum single dose of 80 units5
  • The dose regimen (dose and timing) should be individually adjusted5

Biosimilars

  • In a 2016 report, the EU Commission said: The availability of biosimilars … offers potential economic benefit to healthcare systems, while supporting patients’ access to new treatment options brought about by advances in medical science 6
  • NICE Key therapeutic topic (KTT15) recommends ensuring that all biological medicines, including biosimilar medicines, are prescribed by brand name so that products cannot be automatically substituted at the point of dispensing.7

Bioequivalence

  • A study to compare the pharmacokinetics (PK) and pharmacodynamics (PD) of MYL-1501D (Semglee) with Lantus® in patients with T1DM demonstrated bioequivalence with both US and European insulin glargine; Semglee has a similar PK profile to the reference product and the PD data support the PK results1,8
  • INSTRIDE 2 (a non-inferiority study to compare the efficacy and safety of Mylan’s insulin glargine with Lantus in type 2 diabetes mellitus patients) demonstrated non-inferiority between MYL-1501D and the reference product for reduction of glycated haemoglobin (HbA1c) during 24 weeks of treatment.3

Study evidence—efficacy

  • A review of insulin analogues in T1DM found similar changes in HbA1c and self-monitored blood glucose from baseline to week 24 for Semglee and reference insulin glargine2
  • An open-label randomised study comparing the efficacy of Semglee with Lantus in 560 patients with T2DM, found that Semglee had equivalent efficacy to Lantus in the reduction of HbA1c:3

Change in HbA1c

Study evidence—safety

  • In the INSTRIDE 2 study group of 560 patients, hypoglycaemia was the most common treatment-emergent adverse event (TEAE) in both treatment groups (62 patients [22.5%] in the MYL-1501D group and 56 patients [19.9%] in the reference product group)3
  • The overall and nocturnal rates of hypoglycaemia (episodes/30 days) were similar between treatment groups throughout the 24-week study3
  • No statistically significant differences in hypoglycaemia rate or incidence profile were observed between the Semglee and reference product groups at any visit.3

Device

  • The Semglee pen is based on the comparable insulin delivery pen: the Lantus® SoloStar® *, in size and function:
    • it is designed to be used for multiple subcutaneous injections with disposable needles
    • the pre-filled pen gives patients dosing flexibility, allowing up to 80 insulin units with a single injection
  • Patients who are already using the reference insulin glargine and the reference pen should notice no major differences when transitioning to Semglee and the pre-filled pen.

Semglee Pen

Cost

  • NHS England’s targets for the adoption of best-value biologics are:9
    • 90% of new patients starting on the best-value biologic (including biosimilars) within 3 months of product launch
    • 80% of applicable existing patients switched to the best-value biologic (including biosimilars) within 12 months or sooner if possible (except if standard treatment course is less than 6 months)
  • Semglee NHS list price is >20% lower than the reference product.4

Adverse events

  • The incidence of TEAEs was generally similar for patients on Semglee and patients on Lantus: 64.1% and 58.2%, respectively, experienced at least one TEAE over 24 weeks3
  • See the Summary of Product Characteristics for full details of undesirable effects.5

References

  1. European Medicines Agency (EMA). Assessment report: Semglee. EMA/119474/2018. Available at: www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_assessment_report/human/004280/WC500249349.pdf (accessed 30 October 2018)
  2. Blevins T, Barve A, Sun B et al. Diabetes Obes Metab 2018; doi: 10.1111/dom.13322
  3. Blevins T, Barve A, Sun B et al. Diabetes Obes Metab 2018; doi 10.1111/dom.13495
  4. MIMS online. (accessed 19 October 2018)
  5. European Medicines Agency. Semglee product information. Available at: www.ema.europa.eu/documents/product-information/semglee-epar-product-information_en.pdf (accessed 19 October 2018)
  6. EU Commission. What you need to know about biosimilar medicinal products. Available at: www.medicinesforeurope.com/wp-content/uploads/2016/03/biosimilars_report_en.pdf (accessed 19 October 2018)
  7. NICE. Biosimilar medicines. Key therapeutic topic (KTT15). NICE, 2016 (last updated 2018). Available at: nice.org.uk/guidance/ktt15 (accessed 19 October 2018)
  8. Heise T, Tagore R, Donnelly C et al. Poster 1019-P. Presented at the 77th Scientific Sessions of the American Diabetes Association, June 9–13, 2017, San Diego, CA.
  9. NHS Commissioning Support. Toolkit for implementing best value adalimumab, updated August 2018. NHS Specialist Pharmacist Service. Available at: www.sps.nhs.uk/articles/adalimumab-toolkit-for-commissioners-and-providers/ (accessed 19 October 2018).

 

* Lantus and Solostar are registered trademarks of Sanofi.

 

INS-2018-0019

Date of preparation: October 2018

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