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.”

"“The pharmacist helped by providing additional information and showed me the injection device for the biosimilar and informed me about the patient support program associated with the biosimilar.”

Biologics and switching

Biologic medications have revolutionized treatment of inflammatory forms of arthritis, and given many Canadians back their quality of life by improving symptoms and reducing relapses or flares. 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.  In some cases, it may introduce some benefits.

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?

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. Many biologics must be injected under the skin (subcutaneously) or administered by intravenous (IV) infusion since they are broken down by the process of digestion when taken by mouth.

Biologics are complex, large biological compounds, and they work by targeting problem proteins. This in turn calms the immune system and decreases stiffness, pain and other symptoms of inflammatory arthritis. These medicines are made through complex manufacturing processes involving livings cells, so these drugs are grown rather than chemically made. While expensive, biologics have been in use since the early 1990s.  The term “biologics” refers to both innovator biologics, the original patented medication, as well as biosimilars.

What are innovator biologics and how do they compare with biosimilars?

Innovator biologics are the first medication of their kind to be approved by Health Canada. They are also known as originator biologics or reference biologics. These medications must undergo multiple clinical studies to assess the efficacy and safety of the medication in people with disease, often comparing with placebo. It can take 8 to 15 years or longer for a biologic to be developed and authorized for use in Canada. The innovator biologic is covered under patent protection, meaning that only the pharmaceutical company that holds the patent is allowed to make and sell the drug. Patent protection on pharmaceuticals in Canada lasts 20 years.

Biosimilars are highly similar versions of the innovator 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 and there are no expected clinically meaningful differences in efficacy and safety. For a biosimilar to be approved for sale in Canada, the manufacturer must provide information to Health Canada that demonstrates the similarity of their biosimilar to the innovator biologic. The biosimilar must undergo structural and functional studies as well as human clinical studies to demonstrate comparable quality, safety, and efficacy of the biosimilar to the reference biologic.

While innovator biologics and biosimilars are very similar to one another, we cannot say they are exactly the same. This is because of the inherent variability of complex biological compounds. You can think of biologics like apples growing on a tree. There is inherent variability in each apple, even those that grow on the same tree. This is because apples are complex with many factors affecting their growth. Similarly, batches of biologics made will vary slightly from batch to batch with the same manufacturer. However, you can think of regular chemical drugs such as aspirin (acetylsalicylic acid or ASA) to be like coins. When coins are produced, each one is identical to the rest because the manufacturing is reproducible and there is no inherent variability in the product. They remain identical even when produced in a different year.

Why are biosimilars less expensive than innovator biologics?

While biosimilars are highly similar to the innovator biologic, they are generally less expensive. This is in part because it is less expensive for a pharmaceutical manufacturer to create a copy of an effective drug than to develop an entirely new drug and conduct all the clinical studies needed to get the drug approved. These reduced costs can help more patients gain access to these life-changing therapies and can allow government and other payers to allocate the cost-savings towards funding other products and programs that will improve the health of Canadians.

“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. They recognize the clinical studies comparing the efficacy and safety of the originator biologics with the respective biosimilars showing no clinically meaningful differences between them. 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. Since we are all individuals, there may be the rare situation where switching to a biosimilar may not be right for you and you should speak with your physician about your circumstances and options. For some, a biosimilar my offer an easier-to-use injection device or a more convenient clinic location for the medication administration.

“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 by infusion. Each biologic and biosimilar product has an associated patient support program which helps to connect patients with an infusion clinic and a pharmacy, and you have the option to let the program know your preference. Often patient support programs will help to coordinate the delivery of your medication from the pharmacy to the infusion clinic, so patients just have to show up for their appointment to receive their infusion. They don’t need to worry about obtaining the medication themselves beforehand and dealing with the refrigeration and storage. Patient support programs may also help patients with the drug coverage process, whether it is public or private health coverage.

Sometimes, when patients change to a different biologic or change from an originator biologic to a biosimilar, they may be asked to switch to a different infusion clinic. This could be because the clinic they were previously going to is not setup to provide the patient’s new medication. Don’t be afraid to discuss your options with your doctor. No matter what drug you are on, you will be connected to the supports you need. 

“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 some provinces and territories making this policy change?”

To ensure a sustainable healthcare system, public and private payers are looking at policy changes to reduce expenditures on drugs. One option is to increase uptake of biosimilars: they are safe and effective, and less expensive than originator biologics, 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.  These approaches are expected to help ensure the sustainability of the healthcare system because the expense of the biologics has been perceived as being high.

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.