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Biologic Biosimilars

Biologics

Over the past 18 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 biologic originator. They are typically prescribed to patients by a rheumatologist. For example, etanercept (Brenzys®) and etanercept (Erelzi®) are biologic biosimilar versions of the biologic originator etanercept (Enbrel®).

A biologic biosimilar enters the market after a biologic originator patent expires, just like a small molecule generic medication can do 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 biologic 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 biologic originator 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 biologic originators.

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. Twelve biosimilars are currently approved by Health Canada with another 15 biosimilars expected to be launched by 2020. Since the European Union approved the first biosimilar in 2006, and in inflammatory arthritis in 2013, the EU has approved 40 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 can 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 add new medications coming into the market place, and by doing so, expanding patient medication choice.
  3. Savings from biosimilars can be invested into non-medication types of care that patients need, such as specialized nursing, counselling, physio and occupational therapy, among other important elements of a holistic inflammatory arthritis treatment plan.
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. A study commissioned by the Patented Medicine Prices Review Board (PMPRB) and conducted by the National Prescription Drug Utilization Information System (NPUIS), "Potential Savings from Biosimilars in Canada", estimated potential annual savings for infliximab alone in Canada could range between $91M and $514M in the third year following biosimilar entry.

To learn more about biosimilars, visit the following resources: