Biosimilars: An Important Solution for Health Care Sustainability and Patient Care
Over the past 50 years biologic medicines have revolutionized the treatment and prevention of many disabling and life-threatening diseases, including diabetes, arthritis, inflammatory digestive disorders and cancers.
But biologic medicines are also expensive. It can cost $10,000 to $25,000 or more to treat one patient on a biologic drug for a year. Public and employer-sponsored drug benefit plans want to expand their coverage of patients to include more innovative new medicines, but they also need to manage costs as the number of patients taking biologic drugs continues to grow.
Biosimilars are an important solution in ensuring the sustainability of drug programs to ensure patients have access to the essential therapies they need for years to come.
Fortunately, an important solution to this challenge has arrived in Canada. Patents on many biologic medicines have expired, and other manufacturers are now able to produce these medicines. These are called biosimilars. Thirty-six biosimilars had been authorized for sale by Health Canada by the end of May 2021, and many more submissions for new biosimilars are under review.
Biosimilars have been a standard fixture in patient care in Europe for more than a decade, and continue to grow in Canada with more than 644,000 retail prescriptions filled with biosimilars during the 12 months ending in March 2021, according to IQVIA data. In addition, many biosimilars are used in hospitals for oncology and other conditions, which are not reflected in retail prescription data.
Canada Behind Other OECD Countries in Use of Biosimilars
A 2020 report from the Canadian Institute for Health Information (CIHI) found that biosimilars accounted for only 22,9% of use when available, and has been slower in Canada than in other Organisation for Economic Co-operation and Development (OECD) countries. The Patented Medicine Prices Review Board (PMPRB) estimates that if the uptake of biosimilars in Canada had matched the OECD median average at current prices in 2018, Canada’s savings from biosimilars would have increased from an estimated $94 million to $346 million. A report from the Ontario Drug Policy Research Network (ODPRN) found that provincial drug plans in Canada could save up to $426 million annually by switching patients to biosimilar adalimumab, etanercept and infliximab.
Switching to Biosimilars is Safe and Effective
Patients with chronic diseases typically use a biologic medicine for many years. As such, biosimilars cannot fully contribute to health care sustainability unless patients on existing original biologic medicines transition to biosimilar medicines. Health Canada’s Biosimilars Fact Sheet confirms patients and health care providers can have confidence that biosimilars are effective and safe for each of their authorized indications, and that no differences are expected in efficacy and safety following a change in routine use between a biosimilar and its reference biologic drug in an authorized indication.
Real-word evidence confirms that patients, healthcare providers and payers can have confidence in the well-established practice of transitioning patients from an original biologic drug to a biosimilar. A peer-reviewed study found that there have been more than 178 clinical trials worldwide involving approximately 21,000 switched patients which confirm that switching from an originator biologic drug to a biosimilar biologic drug is not associated with any major efficacy, safety, or immunogenicity issues.
Such proactive switching biosimilar switching policies have already been implemented by the provincial drug plans in British Columbia, Alberta and New Brunswick, and Quebec recently announced its intention to move forward with a biosimilar switching policy soon. Private insurers insurers like Green Shield Canada and Pacific Blue Cross have also embraced biosimilars and encourage biosimilar switching. Such policies are also in place in many European countries.
The Bottom Line
Patients and clinicians can have confidence in biosimilar medicines. Biosimilars are reviewed and authorized for sale by Health Canada, they are as safe and effective as the corresponding original biologic drug, and they can provide tremendous value to Canada’s health care system.
Switching patients from original biologic drugs to new biosimilar medicines is a responsible choice for those who manage drug budgets, and will help to ensure patient access to essential treatments for years to come.