Additional Resources

In May of 2019, British Columbia launched its Biosimilars Initiative. Since then, many provinces and territories have followed suit and patients have successfully switched from originator biologics to covered biosimilars.

The goal? To provide people with safe and effective medications and free up healthcare dollars to fund new, innovative treatments.

Please review the frequently asked questions, videos and other resources below to learn about originator biologics, biosimilars, transition policies and the impact on people living with inflammatory arthritis.

Frequently Asked Questions

What are biologics and biosimilars?

Biologics are medicines taken by IV or self-injection and are made up of large protein molecules derived from living cells. There are now two versions of biologics: “originators” and “biosimilars.” These are near identical copies. The biosimilar has the identical amino acid sequence and is thus an identical twin of the originator. It is also roughly half the price of the originator.
A biosimilar has identical effectiveness, safety, immunogenicity profile and quality and delivers the same therapeutic benefits to patients as its biologic originator.
Biosimilars have been used for many years in chronic diseases such as rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, psoriasis, ulcerative colitis, Crohn’s Disease, cancer and biosimilars have been approved by Health Canada for use in Canada since 2009 and for use in inflammatory arthritis since 2014. Since the European Union approved the first biosimilar in 2006, the EU has approved more than 40 biosimilars.

Why are biologics called biologics?

Unlike regular drugs that are taken as pills and synthesized/produced through a chemical reaction, biologics are drugs that are produced by cells and through a biological process. That is why they are called biologics.

Are biosimilar medications just as safe and effective as biologic originators?

Health Canada’s rigorous standards for authorization mean that patients and health care providers can have the same confidence in the quality, safety and efficacy of a biosimilar as any other biologic medication.
The variation between biosimilars and originators is identical to the variation seen in different batches of the originator agent. That is, the next batch of an originator is akin to a biosimilar of itself.
There have also been more than 90 high-quality, mostly non-industry funded research studies comparing the efficacy and safety of biologic originators and biosimilars, and on the chances of biosimilars triggering immune responses.
Transition policies have been safely and effectively implemented with tens of thousands of patients with autoimmune diseases – such as rheumatoid arthritis, psoriatic arthritis, gastrointestinal and bowel diseases – in many countries in Europe. Registries of these patients on biosimilar therapies report on their continued safe and effective use at leading scientific meetings several times each year, and have done so for nearly a decade.

What does transitioning mean?

Transitioning refers to a one-time change from one medication to another, whether medically necessary or through a reimbursement policy change.
Health Canada considers well-controlled transitions from biologic originator to biologic biosimilar in an approved indication to be acceptable.
Health Canada recommends that a decision to transition a patient being treated with a biologic originator drug to a biosimilar, or between any biologics, be made by the treating physician in consultation with the patient, taking into account any policies of the relevant jurisdiction.
Prior to transitioning, both rheumatologists and their patients must be fully informed about the policy requiring the transition and have all available information about the biosimilar, such as details about the reimbursement policy, patient program information, including contact names and phone numbers.

Why are public and private payers considering implementing biosimilar transition policies?

Provincial, territorial and private health insurers are under increasing pressure to deliver the latest treatments and care to a booming, aging population, most living with at least one, if not several, chronic diseases.
For tens of thousands living with autoimmune forms of chronic diseases such as inflammatory forms of arthritis, diabetes, gastrointestinal, bowel and other chronic diseases, a cornerstone of medication therapy is biologics.
For certain chronic disease patients, there is now at least one other company producing their biologic medication as the patent on their originator version has expired.
This biosimilar has the same therapeutic value as the originator, but costs less than the originators do currently.
The better cost-effectiveness of biosimilars will produce savings for public and private health insurers while having no deleterious effects on patient health and well-being.

Biosimilars are cheaper. Does that mean they're not as good?

No. That is based on very detailed assessments by Health Canada, the European Medicine Agency and similar national government approval mechanisms around the world.
A biologic biosimilar enters the market after a biologic originator patent expires, just like a generic medication can do when the brand name medication’s patent expires.

What specific benefits do biologic biosimilars bring to patients and healthcare systems?

Biosimilars can create two substantial benefits to patients, the healthcare system, and society:

Governments are reinvesting the savings generated from biosimilars in access to new medications that are not currently available, as well as considerably relaxing the rules for access to them. This will be a huge benefit to patients with inflammatory arthritis and psoriasis.
Savings from biosimilars could be invested into non-medication types of care like specialized nursing, counselling, physio- and occupational therapy, and more. In some provinces there are discussions around a triage system to rapidly determine the best therapy track for new onset joint and spinal pain.

Which Canadian provinces and territories have implemented biosimilar transition policies?

When did each province/territory launch its transition policy?

Where are originator biologics and biosimilars made?

It depends on the company making the biologic or biosimilar, but usually in North America or Europe.

Can you explain why someone would stop taking an originator biologic or a biosimilar?

People usually stop taking a medication because it is not working (not effective), stops working, or because they have developed side effects.

Is it possible to do biosimilar-to-biosimilar switches via automatic substitution at the pharmacy/without the knowledge of the treating physician?

No, the health policies for biosimilar transitions don’t permit switching at the pharmacy level. They require a prescription by a doctor and people will continue on the same biosimilar drug by the same company after being transitioned. This is not like a generic.

Videos

Biosimilars: What You Need to Know

Are you a person living with arthritis? Do you want to learn more about biosimilars and the transition policies being implemented across Canada? Watch this webinar recording with Arthritis Research Canada/Arthrite-recherche Canada’s Scientific Director, Dr. Diane Lacaille.

Les biosimilaires : ce que vous devez savoir

Au Canada, la Colombie-Britannique et l’Alberta ont mis en œuvre avec succès une politique de transition vers les biosimilaires, sans aucun compromis en matière d’innocuité, d’efficacité et de qualité des soins.

Dr. Diane Lacaille on Biosimilars Efficacy and Personalizing Care in Arthritis

Cheryl Koehn, Founder and President of Arthritis Consumer Experts, discusses biosimilars efficacy for people living with arthritis, personalizing care, and health inequities in arthritis with Arthritis Research Canada’s Scientific Director, Dr. Diane Lacaille.

Cheryl Koehn with John Esdaile – Transitioning from Biologics to Biosimilars

Cheryl Koehn, Founder and President of Arthritis Consumer Experts, interviews Dr. John Esdaile, Scientific Director Emeritus of Arthritis Research Canada, on transitioning patients from biologics to biosimilars.

The Implementation of the Ontario Biosimilars Transition Policy

In this episode of Arthritis At Home, Cheryl Koehn, President of Arthritis Consumer Experts, speaks to Dr. Jane Purvis, an Ontario rheumatologist and the Chair of Government Affairs Committee of the Ontario Rheumatology Association, about the biosimilars transition policy being implemented in Ontario.

Articles

From Biologics to Biosimilars: The Art of Equivalence

Experts, including Arthritis Research Canada’s Scientific Director Emeritus, Dr. John Esdaile, discuss the movement to biosimilars.

Opinion: B.C. Leads North America Into Next Generation of Biologic Therapy

Arthritis Research Canada’s Scientific Director Emeritus, Dr. John Esdaile, as well as Clinical Trialist, Kamran Shojania, and Cheryl Koehn, President of Arthritis Consumer Experts, share facts and their opinions about biosimilars.

B.C. Expands Use of Biosimilars to Offer Coverage for More Treatment Options

British Columbia is improving the sustainability of its PharmaCare program by expanding the use of biosimilars, which will create opportunities for new drug listings and boost existing coverage for patients.

Alberta, Canada, Sees Early Success From Switching Patients to Biosimilars

Following the launch of its Biosimilars Initiative in December 2019, Alberta, Canada, has succeeded in switching 16 per cent of patients from use of seven reference products to approved biosimilar versions, according to a presenter at the Terrapinn Festival of Biologics Basel 2020.

Alberta Changing Coverage for Thousands of Residents on Biologic Drugs

The Alberta government will change drug coverage for 26,000 residents in an effort to save money, it announced today – meaning those with diabetes, rheumatoid arthritis and Crohn’s disease will soon have to switch to cheaper treatments.

Alberta, Canada, Begins Mandating Switches From Originator to Biosimilar Humira

Alberta, Canada has expanded its biosimilar switching program to include Humira (adalimumab) for all the originator indications except pediatric juvenile idiopathic arthritis, according to Alberta Blue Cross.

New Brunswick Becomes Third Province in Canada to Implement Biosimilar Switching Policy

Biosimilars Canada, a national association representing Canada’s biosimilar medicines industry, today congratulated the Government of New Brunswick for implementing a biosimilar “switching” or transitioning policy to expand the use of biosimilar medicines under the province’s public drug plans.

Northwest Territories Becomes Fifth Jurisdiction in Canada to Implement Biosimilar Switching Initiative

Biosimilars Canada, a national association representing Canada’s biosimilar medicines industry, today welcomed the announcement by the Government of the Northwest Territories that it will implement a “switching” or transitioning policy to expand the use of biosimilar medicines under its public drug programs.

Public Advisory: Newfoundland and Labrador Expanding Safe Use of Biosimilars

The Government of Newfoundland and Labrador will be expanding the use of biosimilar drug treatments offered through the Newfoundland and Labrador Prescription Drug Program. Under this initiative, to maintain coverage, beneficiaries currently using one of the originator biologics of Copaxone®, Enbrel®, Humalog®, Humira®, Lantus®, Lovenox®, NovoRapid®, Remicade® and Rituxan® will be transitioned to a safe, effective and less costly biosimilar version on or before March 31, 2024.

Nova Scotia Moving to Biosimilar Drugs for Pharmacare Programs

Starting today, February 4, Nova Scotians enrolled in Pharmacare programs will begin switching to a biosimilar version of certain biologic drugs, including some insulins and medications used for treating Crohn’s disease and rheumatoid arthritis.

Ontario Expanding Safe Use of Biosimilars

Ontario is joining several other provinces and territories by expanding the use of biosimilar drug treatments for Ontarians.

Saskatchewan Becomes Sixth Canadian Province to Implement a Biosimilar Switching Policy

The Saskatchewan Ministry of Health announced that it will implement a biosimilars switching policy, making it the sixth Canadian province and seventh jurisdiction to do so. Saskatchewan joins British Columbia, Quebec, Alberta, New Brunswick, Nova Scotia, and the Northwest Territories.

Innovative Treatments Pave the Way for Better, Stronger Healthcare System

Biosimilars offer patients and clinicians hope, increasing access to new innovative treatment options.

Biosimilars Perform Identically to Originator Biologics in Natural Experiment

Real-world, population-based data suggest that the discontinuation rates for biosimilars prescribed to treat inflammatory rheumatic diseases are similar to those for their corresponding originator biologics, according to a study of patients in British Columbia who were required to switch to biosimilars.

Yukon Government Enhances Public Drug Plan with Biosimilars

The Government of Yukon is committed to building a sustainable, people-centered approach to improving health systems. That is why the Yukon government is enhancing the public drug plan with biosimilars.

Quebec Announces Biosimilar Switching Policy

Quebec, Canada has announced a biosimilar switching policy, which is expected to generate annual savings of CA$100 million at its conclusion in 2022.

Marching to the Biosimilar Beat: Questions on Rollout Remain

Living in the United States? Looking for more information about biosimilars? This article is a great place to start.

PEI Expanding Safe Use of Biosimilars

Prince Edward Island is joining several other provinces and territories by expanding the use of biosimilar drug treatments for Island residents.

Rheumatic Disease Awareness Month

In honor of Rheumatic Disease Awareness Month, the American College of Rheumatology (ACR) and our Simple Tasks public awareness campaign have developed resources to help patients understand biosimilar medications and their effectiveness in treating rheumatic diseases.

Helpful Links

Biosimilar Resources by Province/Territory

Biosimilars Canada

Biosimilars Canada is a national association representing the biosimilar medicines industry in Canada.