Managing Arthritis

Biologics and biosimilars

A syringe with colored tubes

Concerned about switching to a biosimilar medication? Here’s what the research says

Monty Bartlett of Richmond, British Columbia started taking an originator biologic medication for his psoriatic arthritis in 2006, which successfully controlled both his arthritis symptoms and his psoriasis. When British Columbia announced that it would transition patients from an originator biologic to a biosimilar, Monty opted to try the biosimilar as soon as possible. Even so, he had some initial concerns.

“I wondered, ‘Am I going to go back a step?’ My doctor was very good at explaining the process, and that helped my decision. I felt very comfortable going forward with it.”

Biologics and switching

Biologic medications have revolutionized treatment of inflammatory forms of arthritis, and given many Canadians back their quality of life. So when you’re living with arthritis and find a medication that works well at controlling your symptoms, it’s understandable that you probably don’t want to change anything! But a change to your prescription doesn’t have to be scary.

For people who are currently taking biologics to manage their inflammatory arthritis, a change from an originator biologic to a biosimilar is proven to be safe and effective. Several Canadian provinces and territories are considering—or have already made—policy changes on the coverage of biologics, and the Arthritis Society is here to ensure you have the reliable, evidence-based answers you need to understand these changes and what they mean for you.

What are biologics and biosimilars?

Biologics are created with living cells, such as bacterial cells, yeast cells, or cells from plants or animals, rather than being manufactured chemically like most other drugs. They are complex, large biological compounds, and they work by blocking problem proteins. This in turn calms the immune system and decreases stiffness, pain and other symptoms of inflammatory arthritis. While expensive, biologics have been in use since the early 1990s.  The term “biologics” refers to both originator biologics, the original patented medication, as well as biosimilars.

Biosimilars are a type of biologic. When a drug manufacturer’s patent for a biologic expires, this means another manufacturer (or the same manufacturer) can produce a very similar version of that biologic, called a biosimilar. It’s not an exact copy, but it’s very close. They are generally less expensive than the originator.

“I’m concerned that a biosimilar won’t work as well as my [originator] biologic medication”

Biosimilars are approved by Health Canada and must meet the same regulatory standards as originator biologics. Health Canada’s position is: “Patients and health care providers can have confidence that biosimilars are effective and safe for each of their authorized indications. Our rigorous standards for authorization mean that you can have the same confidence in the quality, efficacy and safety of a biosimilar as in any other biologic drug.” The Position Paper of the Arthritis Society says that “biosimilars have shown efficacy and safety and have a role to play in the care and management of people living with arthritis.”

“I’m concerned that switching from my originator to a biosimilar will cause a health problem.”

While some people may have this concern, Health Canada, the Canadian Rheumatology Association and other trusted organizations have confirmed that it is safe to switch.  Health Canada states: “No differences are expected in efficacy and safety following a change in routine use between a biosimilar and its reference biologic drug in an authorized indication.” Similarly, the Ontario Rheumatology Association says in its Position Statement that it “recognizes that non-medical switching [transitioning] from innovator to biosimilar biologic medications with approved indications for patients with rheumatic disease is safe and has the potential to save health care system resources.” Of course, if you do have concerns, it’s a good idea to talk about them with your rheumatologist.

Since changing to the biosimilar, which is delivered in a clinic in the same building as his old clinic, Bartlett says “there have been no negative effects that I’m aware of, and one of the remaining patches of psoriasis on my elbow even cleared up completely.”

“I’m concerned that biosimilars are just too new and we don’t know enough about them and how they work for arthritis yet.”

While biosimilars are fairly new to Canada—they’ve been approved for use in Canada since 2009 and for treating inflammatory arthritis since 2014.  Biosimilars have been extensively researched and used in Europe for over 10 years without producing any unexpected safety concerns.

“I’m concerned that I will have to go to a new clinic and won’t get the support that I need.”

Continuity of care is very important. In Canada, some biologics are administered intravenously, also known as infusion. Users go to a clinic set up by the manufacturer (rather than a hospital setting), and patient support groups may be part of the process.  “The Arthritis Society’s position is that if provincial and territorial governments make policy changes on the coverage of biologics, it should be seamless for patients. If patients change to a biosimilar, they should have a similar type of patient support program.

“Why are provinces and territories making this policy change?”

To ensure a sustainable healthcare system, public and private payers are looking at policy changes to reduce drug prices. One option is to increase uptake of biosimilars: they are safe and effective, and generally less expensive which could save millions of dollars. Compared to the European Union and other regions, uptake of biosimilars in Canada has been slow.  To help increase the use of biosimilars, payers are considering policy options that include changing patients on an originator biologic to a biosimilar. The experience in Europe and other places shows no differences are expected in a routine switch between the originator biologic and a biosimilar. Savings from using biosimilars will allow payers to be able to afford new drugs and expand access to medications.

If you or a loved one is living with arthritis, you know how important it is to get current and trusted information, and to advocate for your own health. As provinces and territories consider or proceed with making the switch to biosimilars, it’s essential to have informed conversations with your health care providers. It is also a good idea to learn more about biosimilars from evidenced-informed sources, like the Arthritis Society biologics learning tool or Health Canada’s biosimilar fact sheet.