Biosimilars Resources

Biosimilars in Canada: What inflammatory arthritis patients need to know

Biosimilars infographic

The Biosimilars Infographic is a concise, visual summary explaining what biosimilars are and what biosimilar transition policy (or “switching”) means for patients and the healthcare system. 

Click here to download or print your copy. 

Biosimilars Education Videos

Biosimilars Library

Resources

Health Canada

Canadian Agency for Drugs and Technologies in Health (CADTH)

Canadian Institute for Health Information

Patented Medicines Prices Review Board

Ontario Drug Policy Research Network

International Coalition of Medicines Regulatory Authorities (ICMRA) statement about confidence in biosimilar products

European Medicines Agency and The European Commission: Biosimilars in the EU: Information Guide for Healthcare Professionals

European Medicines Agency: Biosimilars Medicines: Overview

FDA Biosimilars Home Page

 

Biosimilars Glossary

Biologic (originator and biosimilar)

Biologic medicines come from living organisms or from their cells and are often made using biotechnology. They are used to treat diseases and medical conditions including anemia, hormone deficiency, inflammatory arthritis, certain types of cancer, diabetes, inflammatory bowel disease and psoriasis. Biologics are generally larger and more complex than chemically produced medicines.

Biologic biosimilar

As patents expire for originator medicines, manufacturers may produce new versions of the biologic medicines called biosimilars.

To receive Health Canada's authorization for sale, a biosimilar must demonstrate that there are no clinically meaningful differences in terms of physiochemical structure, function, efficacy and safety and immunogenicity. Clinical efficacy studies must demonstrate that the therapeutic effects of the biosimilar (both risk and benefit) are consistent.[1]

After a medicine is authorized for sale, post-market analyses and studies can further demonstrate no meaningful differences in clinical efficacy between a biosimilar and the biologic originator.[2]

Since 2009, Health Canada has approved 33 biosimilars. 

Biologic Originator

Biologic originators are biologic medicines Health Canada has already approved for sale (also known as the reference biologic). When the patent of an originator expires, pharmaceutical manufacturers are allowed to make a biosimilar version of the originator.

Extrapolation 

Health Canada may approve a biosimilar to treat a disease without any clinical trial data to support its use in that disease. Once “biosimilarity” to the originator has been demonstrated, it is no longer a requirement to re-study the biosimilar in all indications previously studied with the originator product. An indication is a term that means the use of a medicine to treat a specific disease. Approval of a biosimilar is not a declaration of bioequivalence with the originator biologic. Post-approval, biosimilars are regulated like any new biologic medicine.

Immunogenicity

The immune system has evolved to recognize foreign proteins in the body. Biologics are usually injected into the body and the immune system often reacts to them. This reaction is referred to as the immunogenicity of the product. Sometimes immunogenicity can only be detected using sophisticated laboratory tests and has no impact on the patient. In other cases, immunogenicity can impact patient safety or how well the medication works.

Health Canada is addressing immunogenicity as part of the comparative clinical trials required for approval of biosimilars. In addition, biosimilar manufacturers are responsible to monitor the immunogenicity potential of the biosimilar after it is on the Canadian market.

Interchangeability

In Canada, interchangeability often refers to the ability for a patient to be changed from one medicine to another equivalent medicine by a pharmacist, without the intervention of the doctor who wrote the prescription when it has been deemed interchangeable by a Provincial or Territorial regulatory body. For instance, this is a common practice for medications that are off patent and have been deemed interchangeable with their generic equivalent.

At present and as it relates to biosimilars, Health Canada has declared biosimilars not to be interchangeable with their biologic originator. Health Canada's authorization of a biosimilar is independent of provincial, territorial, or private drug plan decisions regarding its formulary listing and reimbursement or any decision as to interchangeability between these medicines. According to the new guidance from Health Canada, interchangeability decisions rest with provincial or territorial governments. They also regulate pharmacy substitution practices.

Medical Transitions (switching)

In the case of a patient not doing well on their current biologic originator or biosimilar of choice, a transition (switch) to another biologic originator or biosimilar, or other non-biologic medicine, with a different molecular action is then considered by the patient and their rheumatologist. Transitioning when medically required is important to achieving the best disease control and outcomes.

New Starts

New starts are patients who have been newly prescribed a biologic medicine. For the past six years, provincial drug plan across Canada have listed biosimilars ahead of their biologic originators for treatment-naïve patients (patients who have no previously received the biologic originator).

Policy Transitions

Policy transition (“non-medical switching”) occurs when a public or private drug plan’s reimbursement policy necessitate patients move from their current biologic originator to its biologic biosimilar. Since 2019, public drug plans in Canada have begun implementing transitioning policies that change coverage for specific biologic medicines.[3]


[2] Health Canada: Biosimilar biologic drugs in Canada: Fact Sheet – How we monitor the safety of biosimilars after they have been authorized

https://www.canada.ca/en/health-canada/services/drugs-health-products/biologics-radiopharmaceuticals-genetic-therapies/applications-submissions/guidance-documents/fact-sheet-biosimilars.html#a9

Biosimilars FAQs

Biosimilars Workshop

Arthritis medication naming system

In light of the recent arrival of new classes of medicines for certain types of inflammatory arthritis, such as biosimilars and Janus kinase (JAK) inhibitors, a new naming system for disease-modifying anti-rheumatic drugs (DMARDs) is being adopted in Europe and North America.

Essentially, there are two categories of medications: a group that treats disease symptoms and a group that treats the underlying disease process.

1. Medications to treat symptoms

- non-steroid anti-inflammatories (NSAIDs)

- pain relievers, like acetaminophen (Tylenol®)

- steroids

- opioids (narcotics)

Glucocorticoids (GC such as steroids like prednisone): steroids are often used as a “bridging therapy” or to treat life-threatening or organ-threatening complications of rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, systemic lupus erythematosus, and vasculitis.

Non-steroidal anti-inflammatory drugs (NSAIDs such as aspirin, naproxen and celecoxib): these medications help to reduce the inflammation and pain caused by rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis and osteoarthritis. Some NSAIDs are available over the counter like ibuprofen (e.g. Motrin or Advil) or naproxen (Aleve) while others require a prescription.

2. Medications to treat the underlying disease

The term “disease-modifying anti-rheumatic drugs” (DMARDs) is used to categorize certain medicines that suppress the disease process that causes the worsening of rheumatoid arthritis, ankylosing spondylitis and psoriatic arthritis, among many other types of inflammatory arthritis. They alter the natural course of the disease. DMARDs suppress the inflammation, slow joint damage, decrease autoantibody levels and have positive effects on long-term functional outcome.

DMARDs now come in all “shapes and sizes” and can be taken by pill, self-injection and infusion (IV). Each DMARD works in a unique way and the decision about which one(s) is best for you is perhaps the most important conversation you can have with your rheumatologist.

In the new naming system for disease-modifying anti-rheumatic drugs (DMARDs), there are classifications for:

Synthetic (or chemical) DMARDs are now divided into:

csDMARDs: Conventional synthetic DMARDs include traditional medications such as methotrexate, sulfasalazine, leflunomide, hydroxychloroquine, gold salts and others.

tsDMARDs: Targeted synthetic DMARDs include only those medications that were specifically developed to target a particular molecular structure such as tofacitinib, baricitinib or apremilast, or agents not focused primarily on rheumatic diseases, such as imatinib or ibrutinib.

Biological DMARDs are now divided into:

boDMARDs: Biological original DMARDs include abatacept, adalimumab, anakinra, certolizumab peogl, etanercept, golimumab, infliximab, rituximab or tocilizumab

bsDMARDs: Biosimilar DMARDs include:

  • - adalimumab (Amgevita®), adalimumab (Hulio®), adalimumab (Hyrimoz®) and adalimumab (Idacio®)
  • - etanercept (Brenzys®) and etanercept (Erelzi®)
  • - infliximab (Inflectra®), infliximab (Renflexis®) and infliximab (Avsola®)
  • - rituximab (Ruxience®), rituximab (Riximyo®) and rituximab (Truxima®)