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Facts about biosimilar biologics

Biologic medications have been a treatment option for patients with inflammatory arthritis for over the past 21 years. Today, there are biosimilar biologic ("biosimilars") versions of originator biologic ("originator") medicines that have lost patent protection. To receive Health Canada's authorization, a biosimilar must demonstrate that it is highly similar and has no clinically meaningful differences in safety and efficacy compared to the originator.[1]

A biosimilar is typically prescribed to patients by a rheumatologist. For example:

  • adalimumab (Amgevita®), adalimumab (Hadlima®), adalimumab (Hulio®), adalimumab (Hyrimoz®) and adalimumab (Idacio®) are biosimilar versions of the originator adalimumab (Humira®);
  • etanercept (Brenzys®) and etanercept (Erelzi®) are biosimilar versions of the originator etanercept (Enbrel®);
  • infliximab (Inflectra®), infliximab (Renflexis®) and infliximab (Avsola®) are biosimilar versions of the originator infliximab (Remicade®);
  • rituximab (Ruxience®), rituximab (Riximyo®) and rituximab (Truxima®) are biosimilar versions of the originator rituximab (Rituxan®)

Biosimilars are not generics of their originators
Biosimilars are similar, but not the same, as their originators

Due to the size, complexity and natural variability of biologic medications, and because biologic medications are made in living cells rather than with chemicals, a biosimilar and its originator can be shown to be similar, but not identical.

For example, the way that biologics are manufactured makes it impossible to produce an exact copy of the molecule. This differs from other pill-form medications you may have taken before. Medications like methotrexate and ibuprofen are made of small chemical molecules, not proteins. When patents expire on small molecule medications and generic versions are authorized for manufacture, exact copies can be made.

Biosimilars have been approved for use in Canada since 2009, and for use in inflammatory arthritis since 2014. There are currently 33 biosimilars approved by Health Canada. The European Union approved the first biosimilar in 2006, and in inflammatory arthritis in 2013, and today totals 72 approved biosimilars.

Based on this scientific evidence and real-world data, rheumatologists across Canada are now regularly prescribing biosimilars for inflammatory arthritis patients newly initiated on adalimumab, infliximab, etanercept and rituximab; and in full consultation with their patients, beginning to transition them from their originator to its biosimilar.

Why have biosimilar biologics been developed and approved?

Biologics are treatments that can help patients with serious diseases such as inflammatory arthritis, cancer, diabetes, inflammatory bowel disease and psoriasis. However, they are complex medications and can be very expensive and time consuming to develop. This can limit patients’ access to these medicines, and can make it difficult for the healthcare system to afford them. What does this mean for provincial drug plans? According to data from the Canadian Institute for Health Information, public drug programs spent $14.5 billion in 2018, which accounted for 43.4% of prescribed drug spending in Canada.[2] In 2018, biologics used to treat diseases like rheumatoid arthritis and Crohn’s disease accounted for the highest proportion of public drug spending for the seventh consecutive year.[3]

Like legislated generic drug savings in Canada, biosimilars have the potential to improve patient access to biologics and save public and private healthcare systems billions of dollars now and over the coming years. A study commissioned by the Canadian Government’s Patented Medicine Prices Review Board (PMPRB) has estimated that private and public drug plans across Canada could save from $332 million CDN to $1.81 billion CDN in the third year following biosimilar entry across a portfolio of products.[4]

Why are biosimilar biologics less costly than originator biologics?

A manufacturer of biologics must spend many years studying a new biologic medicine before it can be approved in Canada. The company then holds a patent on the medicine that prevents other companies from selling that product. This allows the originator manufacturer to earn back the money it spent on bringing the medicine to market. When the patent of an originator expires, other manufacturers are allowed to make a biosimilar version of the medicine. Manufacturers that make biosimilars of other originator medicines do not have the same costs to bring the medicine to market and can therefore offer it at a lower price.[5]

What benefits do biosimilar biologics provide patients and our healthcare system?

Biosimilars create three main benefits to patients, the healthcare system, and society:

  1. Savings from biosimilars use can modernize “special access criteria”. Currently, patients must try and fail treatment on older, less expensive medications. Because biosimilars are significantly less expensive, public and private drug formularies can remove the need for patients to fail on these older therapies before approving reimbursement for them;

  2. Savings from biosimilars use can be reinvested into public and private drug formulary budgets making it possible to improve the sustainability of their drug plans by adding new medication listings and boosting existing medicine coverage for patients; and,

  3. Savings from biosimilars can be invested into non-medication elements of care that patients need, such as specialized nursing, counselling as well as, physio- and occupational therapy.

 

[1] Health Canada Biosimilars Fact Sheet

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

[2] Canadian Institute for Health Information - Prescribed Drug Spending in Canada, 2019, page 7

https://www.cihi.ca/sites/default/files/document/pdex-report-2019-en-web.pdf

[3] Canadian Institute for Health Information - Prescribed Drug Spending in Canada, 2019, page 9

https://www.dropbox.com/s/8axt6loywl9t65r/Screenshot%202020-02-21%2014.51.24.png?dl=0

[4] The Patented Medicines Prices Review Board, Government of Canada. Potential Savings from Biosimilar in Canada poster.

[5] Canadian Agency for Drugs and Technologies in Health (CADTH): Biosimilar Drugs: Your Questions Answered

https://www.cadth.ca/sites/default/files/pdf/biosimilar_drugs_patient_en.pdf