• 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.

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.

• 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.

• 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.

• 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.

• 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.

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

1. 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.
2. 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.

Alberta – Learn More | British Columbia – Learn More | New Brunswick – Learn More | Newfoundland & Labrador – Learn More | Nova Scotia – Learn More | Northwest Territories – Learn More | Ontario – Learn More | Prince Edward Island – Learn More | Saskatchewan – Learn More | Québec – Learn More | Yukon – Learn More

Alberta – December 2019 | British Columbia – May 2019 | New Brunswick – April 2021 | Newfoundland & Labrador – March 2023 | Nova Scotia – February 2022 | Northwest Territories – December 2021 | Ontario – December 2022 | Prince Edward Island – October 2023 | Saskatchewan – October 2022 | Québec – May 2021 | Yukon – March 2023

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

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

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.