Biosimilars

Rheumatoid arthritis (RA) can be tricky to treat. Despite best efforts, we don’t yet have a way to predict which medication will work best for a particular person. However, when biologic medications were introduced a little over 20 years ago, it was a game changer for RA treatment.  

Thanks to biologics and other treatments, RA is increasingly becoming an invisible illness. For those of us who grew up in a time when no treatments were available, this development is nothing short of a miracle.  

Unfortunately, these wonder drugs are expensive. Biologic medications can cost upwards of $20,000 a year, which creates a significant burden for those who need them. In fact, in 2020, Canada alone spent a staggering $10 billion on biologic drugs.  

Enter biosimilars, a more affordable medication equivalent. The question remains: Will this change access to RA treatment in Canada?  

What Are Biologics and Biosimilars?

Biologic medications consist of complex, large-molecule compounds derived from living cells of plants or animals, which sets them apart from other types of drugs like Tylenol and Methotrexate that are made from small-molecule chemicals. This difference is crucial when discussing generic versions of medications.  

When a pharmaceutical company creates a new medication, it is protected by a patent for a set number of years to prevent the production of generic versions. Once the patent expires, other companies are allowed to create generic versions of the drug. Although generic drugs contain the same medication, they may have different binding agents. 

However, due to the complex nature of biologics, creating an exact copy in the form of a generic drug is impossible. Therefore, the term “biosimilar” is used to describe drugs that work similarly to the original biologic medication but are not identical copies. For more information on this topic, refer to the CreakyJoints Breaking Down Biosimilars podcast. 

Biologic and biosimilar medications treat various conditions, including autoimmune arthritis, migraines, and cancer. Depending on the condition being treated, these drugs target different cells within the body. In this article, we specifically focus on biosimilars used to treat rheumatoid arthritis. 

Will Your Funding Source Force You to Switch to a Biosimilars?

Biologics have had a significant impact on treating rheumatoid arthritis (RA). Still, with yearly costs ranging from $10,000 to $20,000, many patients cannot afford these miracle treatments without the help of private health insurance or provincial drug support programs. Unfortunately, many private health insurance plans do not cover biologics, leaving patients to rely on the provincial programs. These programs offer funding for those with high medication costs, with usually a quarterly deductible based on income. Although patients contribute a fraction of their medication costs, the drug support program pays for most. 

As much as I’m a fan of biologics, I understand that they are ridiculously expensive. When a government spends taxpayer money on treatments that cost billions of dollars year after year, they need to find the least expensive way to do so. But biosimilars usually cost 50 percent to 60 percent of the corresponding biologic and that could mean a lot of money saved.  

Due to this cost-saving potential, eight of Canada’s provincial and territorial governments have established biosimilar switching programs. For example, the British Columbia (BC) provincial drug program, PharmaCare, created the Biosimilars Initiative for Patients in 2019, expanding health care services in BC by switching patients from the original reference biologic to the equivalent biosimilar.  

Similarly, the Ontario Drug Benefit program (ODB) has required those with a new prescription for a biologic to use a biosimilar for several years. However, people who were already using a biologic were allowed to continue. Recently, Ontario created a biosimilar switching policy, which requires those who rely on ODB to switch to a biosimilar by the end of 2023.

In a statement, Ontario’s Health Minister, Sylvia Jones, said this would allow the province to invest more money in new drug treatments and add more options to funded medications. 

The writing is on the wall: If your province has not yet established a biosimilar switching policy, they plan to do so. If you rely on a provincial program for funding your biologic treatment, you will likely be required to switch to a biosimilar.  

Private health insurance plans are also heading in that direction. However, the forced switch for non-medical reasons is controversial. While everyone can support having less expensive options, the concern is that patients who switched to a biosimilar and experienced a flare should be allowed to return to the original biologic.  

To my knowledge, if this happens, the patient’s rheumatologist needs to apply to the government for exceptional use permission on compassionate grounds. The Arthritis Society supports Ontario’s change but states that patients who switched to a biosimilar and experienced a flare should be allowed to return to the original biologic. Crohn’s and Colitis Canada support the use of biosimilars in those who have not taken biologics before, but they recommend against switching for people who are already stable on a biologic 

The Hope and Anxiety of Biosimilars

Those of us living with RA understand the importance of finding a less expensive treatment option, especially as we navigate cost-of-living hikes. Biosimilars provide hope to many more people living with RA, and their reduced cost could lead to more people being approved for funding to pay for this type of treatment.  

It may even lead to a time when people can be approved for a biosimilar without having to try a list of other medications first, also known as a fail-first policy. Such a policy shift could help more people gain better control of their RA much faster, and the money saved could be invested in medication development, leading to new treatments that could make a significant difference in people’s lives. 

However, many of us are concerned about the forced switch based on a policy change rather than a medical reason. I share this concern as someone who has been on a particular biologic for 17 years. The biologic has been thoroughly controlling my RA; before it, I had uncontrollable inflammation that destroyed my life. The biologic has saved my life literally and figuratively, and it continues to do so daily. Being forced to switch makes me nervous. 

Although biosimilars have undergone rigorous testing and are approved if shown to be as safe and effective as the reference biologic, those results are from studies that combine responses from a number of people. The question for me is whether the overall effect will be the same in me as an individual. While many have made the switch without problems, I worry that the slight difference between my biologic and its biosimilars could lead to a different reaction from my body. Additionally, if you go off a particular biologic, you may not respond as well to that medication later. 

Growing up in a time without treatment meant that RA has severely damaged my body. By age 16, I was a power wheelchair user, and the uncontrolled RA I had in the 2000s caused increased disability. My primary health goal is not to become more disabled than I already am. I have been mostly stable for 17 years now, but I know this stability is a very precariously balanced state of health.  

One nudge — an illness, an injury, a switch to another medication — could topple my life. I would be the one bearing the consequences of this, consequences that could include losing the ability to work, even part-time as I do, going for long walks in my wheelchair, buying my groceries, and getting through the day with a relatively manageable level of severe chronic pain. The thought of losing that and the ability to live my life is terrifying. 

Whether you are nervous like me or feel more hopeful about starting a biosimilar, it is important to talk to your doctor about the switch. Ask if you can have some extra time to have an in-depth conversation to answer all your questions without feeling rushed. You may also want to loop in your pharmacist, as they can be a good source of medication information. 

On an individual level, biosimilars have expanded RA treatment options in Canada. They offer more options at less cost, increasing your ability to find a treatment that can effectively control your RA. However, the impact of biosimilar switching policies on rheumatology treatment across Canada is still developing. The use of biosimilars has been slow to grow in Canada, so the data on larger scale effects on rheumatology treatment is still developing. 

There is also a question of how the saved funds will be used. Both communities of those who can be treated with biologics and biosimilars, and the agencies that serve them, are calling for these savings to be used meaningfully. This could include providing access to these kinds of treatments for people or reinvesting the saved funds in developing new medications for these conditions. 

Overall, biosimilars can potentially create a great deal of positive change in the treatment for RA and many other conditions. However, the actual impact of increasing biosimilar use remains to be seen. 

Biosimilars Available in Canada

By February 2023, several biosimilars had been approved by Health Canada to treat RA and they are listed below, along with the names of the reference biologic. This list will expand as the patents for other Biologics expire. 

  • Adalimumab (Humira): Abrilada, Amgevita,Hadlima,Hulio, Hyrimoz, Idacio. Simlandi.
  • Etanercept (Enbrel): Brenzys, Erelzi, Rymti.
  • Infliximab (Remicade): Avsola, Inflectra, Ixifi, Remsina, Remsina SC, Renflexis.
  • Rituximab (Rituxan): Riabni, Riximyo, Ruxience, Truxima

 

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Sources:

Arthritis Society. (n.d.). Biologics & Biosimilars Drugs for Arthritis treatment. Biologics & Biosimilars Drugs for Arthritis Treatment, Arthritis Society Canada. March 15, 2023. https://arthritis.ca/treatment/medication/biologics-and-biosimilars.  

Arthritis Society (n.d.). Access to Medication: Biosimilars: The Arthritis Society Position on Biosimilars. Arthritis Society. March 15, 2023. https://arthritis.ca/getmedia/b30109cd-b6c3-487a-913d-be036114bc96/Biosimilars-position-March-2019.pdf.  

Biosimilars. Arthritis Research Canada. (2022, December 21).  March 15, 2023. https://www.arthritisresearch.ca/biosimilars/ . 

Biosimilars approved in Canada. GaBi Online. (n.d.). March 15, 2023. https://www.gabionline.net/biosimilars/general/biosimilars-approved-in-canada.  

Editorial Team. (2023, March 1). Pharmaceutical Drug Development (Small Molecules / Large Molecules). Contract Laboratory Blog. March 15, 2023. https://blog.contractlaboratory.com/pharmaceutical-drug-development-small-molecules-large-molecules/.  

Ferguson, R. (2022, December 20). Ontario to swap original brand-name drugs with cheaper ‘biosimilar’ drugs for seniors, people on Social Assistance. thestar.com. March 15, 2023. https://www.thestar.com/politics/provincial/2022/12/20/ontario-to-swap-original-brand-name-drugs-with-cheaper-biosimilar-drugs-for-seniors-people-on-social-assistance.html.  

Fleischmann, R, et al. (2021). Non-medical switching from originators to biosimilars in patients with rheumatic disease in routine clinical care: What is the best strategy? Current Rheumatology Research. 2021. doi: https://doi.org/10.46439/rheumatology.2.010.  

Patented Medicine Prices Review Board Canada. Biosimilars in Canada: building momentum in the wake of recent switching policies. Canada.ca. March 16, 2023. https://www.canada.ca/en/patented-medicine-prices-review/services/npduis/analytical-studies/slide-presentations/biosimilars-cadth-2021.html.  

Health Canada. (2019, August 27). Biosimilar biologic drugs in Canada: Fact Sheet. Canada.ca. March 15, 202. https://www.canada.ca/en/health-canada/services/drugs-health-products/biologics-radiopharmaceuticals-genetic-therapies/applications-submissions/guidance-documents/fact-sheet-biosimilars.html.  

Health Ministry of British Columbia. (2023, February 1). Biosimilars initiative for patients. Province of British Columbia. Retrieved March 15, 2023. https://www2.gov.bc.ca/gov/content/health/health-drug-coverage/pharmacare-for-bc-residents/what-we-cover/biosimilars-initiative-patients.  

Kaplan, G, et al. The argument against a biosimilar switch policy for infliximab in patients with inflammatory bowel disease living in Alberta. 2020. Journal of the Canadian Association of Gastroenterology. doi: https://doi.org/10.1093/jcag/gwz044 . 

McClean, AR, et al. Uptake of biosimilar drugs in Canada: Analysis of provincial policies and usage data. 2020. Canadian Medical Association Journal. doi: https://doi.org/10.1503/cmaj.211478.  

Murdoch, B., & Caulfield, T. The law and ethics of switching from biologic to biosimilar in Canada. Journal of the Canadian Association of Gastroenterology. 2020. doi: https://doi.org/10.1093/jcag/gwz043.  

Ontario Ministry of Health. Ontario Expanding Safe Use of Biosimilars. Ontario newsroom. March 15, 2023. https://news.ontario.ca/en/release/1002611/ontario-expanding-safe-use-of-biosimilars.  

The Pharmacy Consulting Team at TELUS Health. Drug plans decoded: Biosimilars part 1. Health Benefits Hub. March 15, 2023. https://plus.telushealth.co/blogs/health-benefits/en/drug-plans-decoded-biosimilars-part-1/.