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)