What is a biologic?

Biologic drugs come from living organisms or from their cells, and are often made using biotechnology. They are used to treat diseases and medical conditions including anemia, diabetes, inflammatory bowel disease, psoriasis, rheumatoid arthritis, hormone deficiency and some forms of cancer. Biologic drugs are generally larger and more complex than chemically produced pharmaceutical drugs. In Canada, biologic drugs are listed in Schedule D of the Food and Drugs Act.[1]

What is a biosimilar?

A biosimilar biologic drug, or biosimilar, is a drug demonstrated to be highly similar to a biologic drug that was already authorized for sale (known as the reference biologic drug).  Biosimilars were previously known in Canada as Subsequent Entry Biologics (SEBs).  Biosimilars are approved based on a thorough comparison to a reference drug and may enter the market after the expiry of reference drug patents and data protection.[2] 

For more information, please visit Health Canada’s Fact Sheet on Biosimilars at this link.

Our Position on Biosimiliars in Canada

The recent introduction of subsequent entry biologics, or biosimilars, has changed Canada’s healthcare landscape.  Biosimilars offer additional options for managing auto-immune diseases such as rheumatoid arthritis, psoriasis and inflammatory bowel disease.  While the promise of short-term cost savings may encourage the adoption of these agents by payers, it should not compromise patient and physician choice.  Decisions that are driven by price alone can have negative consequences for patients who are well-managed on current treatments.  

At Janssen, we support decisions that preserve choice for physicians and patients.  We strongly believe the use of biosimilars in Canada should be based on what physicians determine is in the best interest of their patients and not driven by efforts that restrict treatment choice in any way, including government-forced switch of an innovator biologic for a biosimilar for non-medical reasons.  New policies designed for biosimilars must maintain an environment that encourages innovation.

We recognize the significant cost pressures on the Canadian healthcare system. We work with private payers, individual provincial governments and the Pan-Canadian Pharmaceutical Alliance to deliver cost effective solutions and ensure patients and physicians have affordable access to our medicines.  

Supporting Patients Beyond Medication

Auto-immune diseases are complex and chronic, and require care beyond medication.  Many patients taking innovator biologics depend on patient support programs, which offer services like access to clinics and reimbursement navigation.  Because the offerings and experiences differ between programs, government-forced switch for non-medical reasons could limit the level of service patients have access to.  Many patients are required to visit clinics several times a year for hours at a time, so the convenience and location of services can potentially have an impact on their experience and care.

As a market leader and pioneer of biologics, we are dedicated to improving the lives of Canadians by bringing new and innovative medicines to Canada. Janssen has an established portfolio of biologics, including STELARA® (ustekinumab) and SIMPONI® (golimumab) as well as REMICADE® (infliximab). We have laid the groundwork for biologic therapies, not just in terms of efficacy and safety, but also by building industry leading patient support programs, including our own Janssen BioAdvance^®.  

Value of Innovative Medicines

It is important to evaluate the benefits of medicines that improve quality of life, while limiting other significant healthcare-related costs such as surgery, hospitalization or lost productivity.  We should not lose sight of the overall value biologics bring to patients and our healthcare system.