Two new biosimilar insulins now available in Canada

Viatris is introducing two new biosimilar insulins in Canada—Kirsty (insulin aspart) and Semglee (insulin glargine). Kirsty (insulin aspart solution for subcutaneous injection, 100 units/mL) is the second biosimilar to Novo Nordisk’s NovoRapid to be marketed in Canada, following Trurapi (Sanofi-Aventis). It is indicated for treatment of children and adults with diabetes who require insulin for the control of hyperglycemia. Kirsty should normally be used in regimens together with an intermediate or long-acting insulin.1 Kirsty is currently supplied in 3 mL disposable prefilled pens. Kirsty 10 mL vials are also approved, but not yet marketed in Canada. They may also be used for continuous subcutaneous insulin infusion (CSII) in pump systems that are licensed in Canada for insulin infusion.1 Semglee (insulin glargine [rDNA origin] solution for subcutaneous injection, 100 units/mL) is the second biosimilar to Lantus (Sanofi-Aventis) to be launched in Canada, following Basaglar (Eli Lilly). It is indicated for once-daily subcutaneous administration in the treatment of patients > 17 years of age with type 1 or type 2 diabetes who require basal (long-acting) insulin for the control of hyperglycemia. It is also indicated in the treatment of children (> 6 years of age) with type 1 diabetes who require basal insulin for the control of hyperglycemia.2 Semglee is currently supplied in 3 mL prefilled disposable pens.2 In a January 2020 position statement on biosimilar insulins, Diabetes Canada recommends that healthcare providers: Consider biosimilar insulins as the first treatment option for insulin-naïve patients where these represent a cost-effective advantage. Consider switching to a biosimilar insulin for patients with sufficient monitoring, if this can be achieved safely and effectively. This should only be considered if there are no clinical or contextual circumstances that might compromise a patient’s health, and with patient discussion and consent. Support a patient not to switch to a biosimilar insulin if they believe the patient has characteristics or circumstances (temporary or otherwise) that would contribute to some lability in their diabetes care or negatively impact other health outcomes. Report any adverse reaction to a biosimilar insulin (as for a biologic insulin), to allow for post-market surveillance. Facilitate patient access to support services, such as education and counselling, to allow for a positive transition, if required. Recommend an increase in the frequency of self-monitored blood glucose testing, review of symptoms, precipitants and treatment of hypoglycemia, and the type and frequency of blood work during the transition period (e.g., A1C). Work together with other healthcare team members to support patients who transition from a reference biologic drug to a biosimilar insulin, and to track the clinical outcomes associated with switching. This will help inform the safety and effectiveness for future patients.3 References 1. BGP Pharma ULC. Kirsty (insulin aspart injection) product monograph. Etobicoke, ON; October 12, 2021. https://pdf.hres.ca/dpd_pm/00063282.PDF (accessed November 10, 2022). https://pdf.hres.ca/dpd_pm/00063282.PDF (accessed November 10, 2022). 2. BGP Pharma ULC. Semglee (insulin glargine injection [rDNA origin]) product monograph. Etobicoke, ON; September 22, 2022. https://pdf.hres.ca/dpd_pm/00067509.PDF (accessed November 10, 2022). 3. Diabetes Canada. Diabetes, biologic drugs, and biosimilar insulins: position statement. January 2020. https://www.diabetes.ca/DiabetesCanadaWebsite/media/Advocacy-and-Policy/Diabetes-Canada_Policy-Position_Biosimilars_January-2020.pdf (accessed November 10, 2022).

Two new biosimilar insulins now available in Canada

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