Biosimilar Initiative

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Overview

The Government of Northwest Territories (GNWT) is launching a Biosimilars Initiative to switch patients from originator biologic drugs to the biosimilar versions. A biosimilar drug is a highly similar but less expensive version of the original biologic medication, known as an originator drug. Expected savings from the implementation of this policy is to be reinvested to help fund coverage by increasing the medications that the supplementary health benefits programs cover in the future.

Health Canada confirms that patients and health-care providers can be confident that biosimilars are as effective and safe as their biologic reference drug. Other federal organizations also support the use of biosimilars.

The Biosimilars Initiative is an evidence-informed strategy to optimize public resources to get the best value for treatments and improve access to medications for patients. Increasing the uptake of biosimilar medicines will contribute to the sustainability of the public drug plans. Similar initiatives have been successfully implemented in British Columbia, Alberta, New Brunswick, and Quebec.

Biologic drugs make up some of largest drug costs incurred by the GNWT’s publicly funded benefit programs and those costs are increasing at an unsustainable rate. In 2020-2021, GNWT’s supplementary health benefit program spending on biologic drugs increased by 17.6% to $2.8 million.

Between December 21, 2021 and June 20, 2022, patients who use certain originator biologics must switch to a biosimilar to maintain their coverage under the Extended Health Benefits Seniors and Specified Disease Conditions, and Métis Health Benefits programs. The six-month transition period will allow patients to speak with their prescriber, to have their questions answered and to obtain a new prescription for the biosimilar to ensure their coverage is maintained. As of June 21, 2022, the GNWT-sponsored programs will cover only the biosimilar versions except through an approved Exception Request.

Table 1: List of Current Originator Biologics and the corresponding Biosimilars eligible for coverage

Active Ingredient

Originator Biologic Product

Biosimilar Product

Health Condition

Adalimumab

Humira®

Amgevita®

Hadlima®

Hulio®

Hyrimoz®

Idacio®

 

 

Ankylosing spondylitis

Crohn’s disease

Hidradenitis suppurativa

Plaque psoriasis

Polyarticular juvenile idiopathic arthritis

Psoriatic arthritis

Rheumatoid arthritis

Ulcerative colitis

Non-Infectious Uveitis

Enoxaparin

Lovenox®

Inclunox®

Noromby®

Redesca®

Thromboembolic disorders

Etanercept

Enbrel®

Brenzys®

Erelzi®

Ankylosing Spondylitis

Plaque Psoriasis

Psoriatic Arthritis

Polyarticular Juvenile Idiopathic Arthritis

Rheumatoid Arthritis

Infliximab

Remicade®

Inflectra®

 

Renflexis®

Avsola®

Ankylosing spondylitis

Plaque psoriasis

Psoriatic arthritis

Rheumatoid arthritis

Crohn’s disease

Ulcerative colitis

Insulin glargine

Lantus®

Basaglar®

Diabetes

Insulin lispro

Humalog®

Admelog®

Diabetes

Insulin aspart

NovoRapid®

Trurapi®

Diabetes

Filgrastim

Neupogen®

Grastofil®

Nivestym®

Neutropenia

Pegfilgrastim

Neulasta®

Lapelga®

Fulphila®

Nyvepria®

Ziextenzo®

Neutropenia

Rituximab

Rituxan®

Truxima®

Riximyo®

Ruxience®

Riabni®[2]

Rheumatoid arthritis

Vasculitis

Autoimmune diseases

Glatiramer[1]

Copaxone®

Glatect®

Multiple sclerosis

1 - Non-biologic complex drug

2 - To be Listed

Biologic and Biosimilar Drugs

Biologics are drugs made in, taken from, or partly made from living cells through a complex manufacturing process. The first version of a biologic drug is called an originator biologic drug but may also be called an innovator or reference biologic.

Health Canada describes a biosimilar biologic drug, or biosimilar, as a biologic drug that is highly similar to an originator biologic drug that was already authorized for sale. There are no clinically meaningful differences in efficacy and safety between a biosimilar and the originator biologic drug previously authorized for sale.

Biosimilars in Canada

How Health Canada regulates biosimilars

  • Biosimilars are approved for sale just as any other drug - they must be evaluated and approved by Health Canada.
  • Health Canada has developed a robust, science-based regulatory framework for authorizing the use and sale of biosimilars.
  • Biosimilars are manufactured to the same regulatory standards as other biologic drugs and are authorized after a scientific evaluation by Health Canada.
  • Rigorous standards for authorization mean that patients can have the same confidence in the quality, efficacy, and safety of a biosimilar as any other biologic drug.
  • Health Canada will not approve a biosimilar for sale unless it is proven to have no clinically meaningful difference to the patient, as compared to the original biologic drug.
  • For additional information about how Health Canada approves and regulates biosimilars, please refer to:

Other Canadian Biosimilar Initiatives

  • In 2019, British Columbia and Alberta implemented biosimilars policies to switch patients from originator biologics to their biosimilars. Tens of thousands of patients in each province were safely switched, including those living with inflammatory arthritis, inflammatory bowel disease, diabetes, and psoriasis. Both provinces have continued to apply their switching policies to new biosimilar medicines as they have become available.
  • In May 2021, the Government of Quebec announced the province's intention to implement a biosimilar switching policy under its public prescription drug insurance plan. By April 13, 2022, all patients currently receiving biologic drug treatment will be switched to the corresponding biosimilar on their List of Medications covered by the basic prescription drug insurance plan.
  • The New Brunswick Department of Health has also launched a Biosimilars Initiative which involves switching patients from originator biologic drugs to their biosimilar versions. Between April 21, 2021 and November 30, 2021, patients who use certain originator biologics must switch to a biosimilar brand to maintain their coverage under the New Brunswick Drug Plans.

Switching to Biosimilars  

  • Further to Canadian initiatives, many European countries have switched patients under their publicly funded plans from originators to biosimilars.
  • There are now more than 75 research studies on biosimilars in rheumatology, gastroenterology, dermatology, and other neurological disorders, which collectively show little to no clinical differences between biosimilars and their biologic originators, either when used with patients who have never undergone treatment for the condition, or for patients switching to a biosimilar.
  • The majority of switching studies also found that efficacy loss associated with switching to biosimilars was the same as is expected for patients who remain on the originator drug.