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Biosimilar Biologics

Biologics

Over the past 22 years in Canada, biologics have become a life-saving treatment option for inflammatory arthritis patients whose disease does not respond, or respond well enough, to conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs) such as hydroxychloroquine or sulfasalazine. Biologics are proven to effectively address disease signs and symptoms – like swelling, pain and fatigue – but also may improve mortality and reduce heart disease and other complications of inflammatory arthritis.

Biologics are made from living organisms, such as living cells that have been modified using biotechnology. This allows these living organisms or cells to produce the active substance (the part that works to treat the disease) of the biological medicine. This active substance is then harvested from the cells. The active substance is commonly called a “protein.” Biologics made up of proteins are much larger and more complex in nature than conventional, small molecule medicines, like over-the-counter ibuprofen (e.g. Advil) or by-prescription methotrexate.

While small molecule medicines are made of pure chemical substances and their structures can be identified, most biologics are complex mixtures of proteins, sugars or nucleic acids that are more difficult to identify or characterize. Because of their complexity, biologics are expensive and time consuming to develop. This can limit patients’ access to such medicines and can make it difficult for the health care system to afford them.

Biosimilars

A biosimilar is a biologic that has similar effectiveness, safety, immunogenicity profile and quality and delivers the same therapeutic benefits to patients as its originator biologic. They are 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 (Avsola®), infliximab (Inflectra®) and infliximab (Renflexis®) are biosimilar versions of the originator infliximab (Remicade®);
  • rituximab (Riabni®), rituximab (Riximyo®), rituximab(Ruxience®) and rituximab (Truxima®) are biosimilar versions of the originator rituximab (Rituxan®).
A biosimilar biologic enters the market after an originator biologic patent expires, just like a small molecule generic medication does when the brand name medication’s patent expires. And just the way generic medications are much lower in price compared to their original versions, so too are biosimilars. For example, a generic aspirin such as acetaminophen is less expensive than brand name Tylenol®. However, unlike generic medications, biosimilars cannot be identical to their originator biologics. 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 biologic can be shown to be similar, but not identical. While this fact remains true, there are now more than 100 research studies, in rheumatology, gastroenterology, dermatology and other diseases, which collectively show little to no clinical differences between biosimilars and their originator biologics.

Biosimilars have been used for many years in other diseases, such as diabetes, growth disorders and anaemia. Biosimilars have been approved for use in Canada since 2009 and for use in inflammatory arthritis since 2014. Thirty-six biosimilars are currently approved by Health Canada. Since the European Union approved the first biosimilar in 2006, and in inflammatory arthritis in 2013, the EU has approved more than 72 biosimilars.

Like any medicine approved by Health Canada, biosimilars can be expected to be safe and effective treatment options when they are used appropriately in their approved indications. Instructions for use are provided in the product monograph and package leaflet. As with any treatment, it is important to have a thorough conversation with your rheumatologist about all the available therapeutic options, their safety, benefits and risks, and the differences between the medications, before coming to a decision.

Why have biosimilars been developed and approved?

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 plans can remove the need for patients to fail on these older therapies before approving reimbursement for biosimilars;
  2. Savings from biosimilars use can be reinvested into public and private drug plan 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, physiotherapy, and occupational therapy.
Like legislated generic drug savings in Canada, biosimilars have the potential to improve patient access to biologics and save public and private health care systems billions of dollars now and over the coming years. The Canadian Government’s Patented Medicine Prices Review Board has estimated that private and public drug plans across Canada could save from $332 million to $1.81 billion in the third year following biosimilar entry across a portfolio of products.

To learn more about biosimilars, visit the following resources: