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

Final version - Semglee FDG_reprint

  • Comparative pharmacokinetic and pharmacodynamic studies have demonstrated the bioequivalence of MYL-1501D (Semglee®) to both US and European reference insulin glargine® in patients with type 1 diabetes mellitus (T1DM)1
  • Semglee has demonstrated equivalent efficacy to Lantus® in the treatment of hyperglycaemia in patients with T1DM already treated with reference glargine and in type 2 (T2DM) patients who are insulin naive or already treated with insulin2,3
  • The Semglee pen is comparable to the insulin delivery pen, Lantus® SoloStar® *, in size and function
  • Semglee NHS list price is >20% lower than the reference product.4

Click here to download a PDF of the formulary decision guide.

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 stated: 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 comparing the pharmacokinetics (PK) and pharmacodynamics (PD) of MYL-1501D (Semglee®) with Lantus® in patients with T1DM demonstrated bioequivalence with both US and European reference 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 comparing the efficacy and safety of Mylan’s insulin glargine with Lantus in T2DM 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

  • An open-label randomised study 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 graph (Semglee FDG)

Study evidence—safety

  • In the INSTRIDE 2 study, hypoglycaemia was the most common treatment-emergent adverse event (TEAE) in both treatment groups (62 patients [22.5%] in the Semglee® 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 comparable to the insulin delivery pen, 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 its 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

  • In the open-label randomised study INSTRIDE 2, 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).

▼ This medicine is subject to additional monitoring. This will allow quick identification of new safety information. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare providers are asked to report any suspected adverse reactions. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard. In order to support effective tracking and traceability of biologics including biosimilars, it is recommended that the brand name and batch number are recorded and used when reporting adverse events. You can also report adverse events direct to the marketing authorisation holder at ukpharmacovigilance@mylan.com

* Lantus and Solostar are registered trademarks of Sanofi.

 

INS-2019-0047

Date of preparation: June 2019