December 12, 2019
For Immediate Release
ARTHRITIS CONSUMER EXPERTS STATEMENT ON ALBERTA GOVERNMENT ANNOUNCEMENT OF BIOSIMILARS POLICY
(Vancouver) – Arthritis Consumer Experts (ACE) today expressed its support of Alberta Health’s announcement of its biosimilar policy, becoming the third province to expand the use of biosimilar medications, following British Columbia and Manitoba’s lead.
“As a person living with rheumatoid arthritis, a volunteer and a health educator, I hear every day how patients like me are struggling to gain reimbursement for treatment and services they and their rheumatologist feel they need. Today’s announcement is a direct answer to this problem, clinically and financially. It ensures continued reimbursement coverage for Albertans who transition to a biologic biosimilar, and through reinvestment of savings, improves models of care for patients living with complex chronic diseases,” said Cheryl Koehn, ACE Founder & President and person living with rheumatoid arthritis. “The key for patients going through policy transition is access to science-based information to support their conversations with their healthcare team. To help inflammatory arthritis patients in Alberta with their discussions, credible information written in patient friendly language on the safety and efficacy of biosimilars can be found on ACE’s website JointHealth.org in the Biosim•Exchange pages.”
Biosimilar versions of original “brand” name biologics have been approved for use in Canada since 2009, and in arthritis since 2014. Eighteen biosimilars are currently approved by Health Canada with another 15 under review. Since the European Union (EU) approved the first biosimilar in 2006, the EU has approved 53 biosimilars. They have become leading treatments in autoimmune mediated diseases such as forms of inflammatory arthritis.
The leading regulators in the world – including the European Medicines Agency, Food & Drug Administration in the U.S and Health Canada – support well-controlled transitions to biosimilars. Patients need to know transition policy has been safely and effectively implemented over the past 10 years with thousands of patients with autoimmune diseases such as rheumatoid arthritis, psoriatic arthritis, and gastrointestinal and bowel diseases in many countries in Europe with no compromise to patient safety, effectiveness or quality of care.
More than 100 research studies exist looking at patients who have successfully policy transitioned from a TNF inhibitor biologic originator to its TNF inhibitor biologic biosimilar and show no health differences between patients.
The most important thing for patients going through a policy transition is access to patient-friendly, science-based information to support their conversations with their health care team. Credible biosimilars information can be found on the ACE website, JointHealth™‘s Biosim•Exchange pages: http://bit.ly/BiosimExchangeEN.
“We’ve learned so much about the biosimilar transition experience from our fellow inflammatory arthritis patients in Europe – thousands have been transitioned to the biosimilar version and the provision of good information during the process was key to their success,” says Koehn. “All biologics – originators and biosimilars – are made in batches, and after the first batch of the originator is gone, every batch thereafter becomes its own biosimilar. For example, I have been on two biologic originators over the past 17 years, and I’ve been transitioned multiple times, from batch to batch to batch, and the benefits and risks to me have remained the same. The same is true for biologic biosimilars: batches are produced following strict guidelines set out by Health Canada. The main differences are biosimilars are produced off-patent and are roughly half the cost of the originator.”
Biologics have been a life-enhancing, and in some cases, life-saving treatment option for patients living with diseases like inflammatory arthritis, diabetes, inflammatory bowel disease and certain types of cancer. Today, there are biosimilar versions of original-brand biologics available to these patients. Health Canada's rigorous standards for authorization mean that patients can have the same confidence in the quality, safety and efficacy of a biosimilar as any other biologic medicine.1
Biosimilar manufacturers must provide information to Health Canada comparing the biosimilar with the original-brand biologic medicine. Similarity is demonstrated beginning with structural and functional studies and continuing with human clinical studies. Because the purpose of these studies is to demonstrate similarity, the type of data required to support biosimilar authorization differs from that required for an original-brand biologic medicine.2
Biosimilar medicines are offered at a much lower cost because they do not require as much research and development as original-brand biologics. The savings generated by biosimilars can be reinvested into healthcare resources and enable more patients to experience the life-enhancing benefits of biologic treatment.
About Arthritis Consumer Experts
Arthritis Consumer Experts (ACE) has been a leader in biosimilars discussions since 2009, sharing information with stakeholders across Canada through free research-based workshops, webinars and education programs. Drawing from this experience, ACE has created the Biosim•Exchange, an information hub for consumers to get the latest biosimilars news and background analysis. http://bit.ly/BiosimExchangeEN.
ACE has produced a special biosimilars education video series, where ACE speaks to medical experts on key patient questions around biosimilars and transitioning from originators to biosimilars: Go to https://biosim.jointhealth.org/resources and click on “Biosimilars education videos.”
ACE has recently published a new guide - “Biosimilars in Canada: What inflammatory arthritis patients need to know” - to address those needs of patients who want information on biosimilar medicines. It aims to provide answers to questions patients may have on biosimilars and provide them the information tools they need to power and support their conversations with their rheumatologists and other health care providers and ensure science-based continuity of care. Click here to view the Guide.
For further information, please contact:
Vice President, Communications & Public Affairs
Arthritis Consumer Experts
1 Health Canada Biosimilars Fact Sheet