Building Competency in Diabetes Education THE ESSENTIALS
BASAL-BOLUS INSULIN THERAPY | 12-30
The biosimilar drug has undergone the same regulatory standard for quality as the original biologic reference drug . However, the manufacturer of the biosimilar drug does not need to prove the original efficacy and safety of the drug as these studies were done when the original biologic came to market. In order to come to market they must prove that the biosimilar medication is ‘highly similar ‘ to the biologic reference medication (48, 49. Structural and functional studies are done comparing the drugs as to product stability, biological activities, physiochemical properties, immunochemical properties and purity profiles. Research trials are conducted directly comparing the biosimilar with the reference biologic to ensure that the clinical effect is truly similar. If all the data supports that the biosimilar is “highly similar’ it is approved for the market (48,49). Once the biologic reference drug has come off patent and no longer has data protection the biosimilar can enter the market (48). The question of interchangeability is often asked. Health Canada does not actually state that the biologic reference drug and the biosimilar are interchangeable but leaves this distinction up to the provincial formularies. Each province will make their own decision as to coverage, language and cost (48) . Currently the biosimilars on the Canadian market are reported on average to cost 20 to 79% less than their reference biologic. (50,51)
Current Insulin biosimilars on the Canadian Market
Biosimilar
Active ingredient
Date on Market
Manufacturer
Reference biologic sponsor
Basaglar
glargine
2014
Eli Lilly
Lantus
Sanofi Aventis
Admelog
Insulin lispro
2017
Sanofi-Aventis
Humalog
Eli Lilly
Trurapi
Insulin aspart
2020
Sanofi-Aventis
NovoRapid Novo Nordisk
Kirsty
Insulin aspart
Oct. 2021
BGP Pharma
Novorapid
Novo Nordisk
Adapted from Health Canada information (48)
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