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Our Position on Biosimilars in Canada

Our Position on Biosimilars 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.

Similar is not the Same

According to Health Canada, biosimilars are not deemed bioequivalent to the reference biologic medicine. Unlike traditional small molecule (chemically-based) medicines, biologics are large proteins derived from living cells. Changes in manufacturing and production practices can introduce differences in the final product of biologic medicines, which may impact effectiveness and, potentially, patient safety. Health Canada does not support automatic substitution of a biosimilar with its reference biologic and recommends that physicians make well-informed decisions regarding the use of biosimilars.

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), approved in 2001 as the first biologic indicated for the treatment of Crohn’s disease. 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.