Karen Bartha shares her top tips on prescribing considerations for biosimilars such as stability, interchangeability/switching, and brand names.

Blackwood karen

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Read this article to learn more about:

  • factors to consider when prescribing a biosimilar insulin 
  • follow up and support after changing to a biosimilar
  • safety concerns and how to improve safety. 

The use of biosimilar insulins is increasing in the UK. There is increasing pressure to save money in the NHS, with some CCGs recommending the use of biosimilar insulins as first-line insulin on their local formulary. Here, we will explore what a biosimilar medicine is, and whether biosimilars are truly the same as their originators.

What is a biosimilar?

A biosimilar medicine is a biological medicine that is highly similar to another approved biological medicine (reference medicine).1 To be licensed by the European Commission on the advice of the European Medicines Agency, biosimilar medicines must have no clinically meaningful differences from the originator medicine in terms of quality, safety, and efficacy.2

Are biosimilars really the same?

The characteristics of biological medicines cannot be reproduced exactly;3 there will be an inherent degree of variability among biological medicines, and minor differences can occur from batch to batch.4 Despite this minor variability, strict controls are in place to ensure that the differences fall within the acceptable range and do not affect safety or efficacy.4 For this reason, with regard to insulin, automatic switching from the reference medicine to a biosimilar medication is not recommended without clinical indication.5

Safety concerns

Biosimilar medicines are approved to the same standards of pharmaceutical quality, safety, and efficacy that apply to all biological medicines.4 If a biological medicine (or biosimilar) is labelled with a black triangle, it does not necessarily mean that additional safety concerns are associated with its use.

Through demonstration of biosimilarity, a biosimilar medicine can rely on the safety and efficacy experience gained with the reference medicine, which avoids unnecessary repetition of clinical trials already carried out with the reference medicine.4

The risk of prescribing and dispensing errors potentially increases as the numbers and types of insulin available rises, and biosimilar insulins add to this complexity.6 HCPs need training to understand the different insulin regimens available and whether they are interchangeable.6

Prescribing considerations

  • Cost
    • biosimilars have the potential to offer the NHS considerable cost savings, especially because they are often used to treat long-term conditions2,3
  • Interchangeability/switching
    • although biosimilar medicines have been shown to have no clinically meaningful differences from the originator medicine in terms of quality, safety, and efficacy, they are not identical and therefore not interchangeable like generic medicines;3,4 people established on insulin who are achieving their target glycosylated haemoglobin (HbA1c) and do not have hypoglycaemia should not be automatically switched to a biosimilar insulin5
  • Brand prescribing
    • to reduce the potential for prescribing errors, prescribers should include the trade name of the medicine in the prescription6—see Table 1
  • Stability and shelf life
    • the stability, shelf life, and storage of biosimilar insulin may differ from that of the reference medication—the summary of product characteristics (SPC) should always be checked6
  • Difference in delivery methods
    • healthcare professionals (HCPs) need to be aware that there may be differences in the delivery devices between the biological medicine and the biosimilar;4 for example, the Abasaglar® device is not identical to the Lantus® device, and cartridges cannot be used interchangeably between reusable pen devices.6

Follow up and support after changing to a biosimilar

Patients should expect to see a similar blood glucose-lowering effect and safety profile as the reference medicine.6 If switching to a biosimilar insulin, individuals will need to monitor their blood glucose levels more closely, which increases both cost and inconvenience.5

Pharmacovigilance considerations

Regarding side-effects caused by biosimilars—what to look out for and what action to take—HCPs should report any suspected adverse reactions to the Medicines and Healthcare products Regulatory Agency (MHRA) in the usual manner, even if the reaction is already listed in the reference medicine’s SPC.4

Table 1: Available biosimilar insulins7
Trade nameDrug name 

Abasaglar 100 units/ml

Insulin glargine

Long-acting analogue insulin

Semglee 100 units/ml

Insulin glargine

Long-acting analogue insulin

Insulin Lispro Sanofi 100 units/ml

Insulin lispro

Rapid-acting insulin analogue

Top tips to improve safety

  • Changes to insulin regimens should only be made by HCPs with relevant expertise and training
  • The decision regarding which insulin is most appropriate should always be made jointly between the person with diabetes and their HCP
  • Prescribers should include the trade/brand name of the medicine in the prescription to avoid prescribing errors
  • People established on insulin who are achieving their target HbA1c and who do not have hypoglycaemia should not be automatically switched to a biosimilar insulin
  • Any adverse reaction to a biosimilar insulin should be reported to the MHRA so that appropriate monitoring can take place
  • HCPs must keep their knowledge of available insulins up to date
  • Biosimilars are similar but not identical and are not direct equivalents of biologics/reference medicine in the same way that generics are equivalent to branded medicines.

Summary

Use of biosimilar insulins has the potential for significant cost savings for the NHS. HCPs need to be updated to understand that although biosimilar medicines have been shown to have no clinically meaningful differences from the originator medicine in terms of quality, safety, and efficacy, they are not identical and therefore not interchangeable like generic medicines.

Further training

References

  1. European Medicines Agency. Guideline on similar biological medicinal products. EMA, 2014. Available at: www.ema.europa.eu/en/documents/scientific-guideline/guideline-similar-biological-medicinal-products-rev1_en.pdf
  2. NHS England. Biosimilar medicines. www.england.nhs.uk/medicines/biosimilar-medicines/ (accessed 19 July 2019)
  3. NICE. Evaluating biosimilar medicineswww.nice.org.uk/news/article/evaluating-biosimilar-medicines (accessed 19 July 2019)
  4. European Medicines Agency. Biosimilars in the EU: Information guide for healthcare professionals. EMA, 2017. Available at: www.ema.europa.eu/en/documents/leaflet/biosimilars-eu-information-guide-healthcare-professionals_en.pdf
  5. Diabetes UK. Our position statement on the use of biosimilar insulin. Diabetes UK, 2018. Available at: www.diabetes.org.uk/resources-s3/2018-08/Our position statement on the use of biosimilar insulin.pdf
  6. Association of British Clinical Diabetologists. Association of British Clinical Diabetologists (ABCD) position statement on the use of biosimilar insulin. BJD 2018; 18 (4): 171–174.
  7. Datapharm Ltd. Electronic medicines compendium. www.medicines.org.uk/emc/ (accessed 19 July 2019)
  8. Diabetes on the Net. The six steps to insulin safety. www.diabetesonthenet.com/course/the-six-steps-to-insulin-safety/details (accessed 19 July 2019)
  9. Guidelines for Nurses. Safer insulin prescribing and ongoing management of individuals taking insulin in primary care. www.guidelinesfornurses.co.uk/diabetes/safer-insulin-prescribing-and-ongoing-management-of-individuals-taking-insulin-in-primary-care/453807.article (accessed 19 July 2019)