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What people are saying about biosimilars

Cheryl Koehn, president of Arthritis Consumer Experts and person living with rheumatoid arthritis –

“In my work leading Canada’s largest arthritis patient organization, I hear every day how patients like me are struggling to gain reimbursement for the medications 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 British Columbians who transition to the next generation biologic and ensures that reimbursement for other patients becomes available. This policy announcement shows how coverage for a few turns into coverage for many. All of society benefits. The most important thing for patients going through a transition is access to patient-friendly, science-based information to support their conversations with their health-care team. We’ve had the good fortune to learn from our fellow inflammatory arthritis patients in Europe – thousands have been transitioned to the newer version of their biologic and good information was key to their success. Patients in B.C. can find good biosimilars information on the Arthritis Consumer Experts website BiosimExchange.”

Dr. John Esdaile, rheumatologist, scientific director, Arthritis Research Canada –

“Today’s announcement is a welcome and important change. For years, B.C. has been spending money it doesn’t need to spend on expensive biologics, instead of using biosimilars – which I refer to as ‘biogenerics’ – which are proven to work just as well. There are enormous amounts of research and experience with biosimilars in Europe, which has saved the health care system billions and provided better care to patients while keeping everyone safe. In fact, the E.U. monitoring system for safety concerns has not identified any relevant differences in the nature, severity, or frequency of adverse effects between biosimilars and their reference medicines over 10 years since approving the first biosimilar back in 2006. It is finally time that PharmaCare stops spending the big bucks and starts to realize the big savings.”

Christine Basque, executive director for B.C. and Yukon, Arthritis Society –

“The evidence now clearly indicates that transition from original biologic to biosimilar can take place safely and without impacting patient care. Our top priority has always been to ensure that patients have access to necessary and appropriate treatments, along with trusted, evidence-based information. We will continue to monitor the implementation of this plan to ensure a seamless transition.”

Dr. Tom Elliott, endocrinologist, medical director, BC Diabetes –

"BC Diabetes welcomes today's PharmaCare announcement of coverage of the SGLT2 inhibitor class, represented by Jardiance, as a third-line agent for Type 2 diabetes. The funds to cover the SGLT2 inhibitor class will come from cost savings realized by the use of the insulin glargine biosimilar Basaglar in place of the biologic Lantus. This change will entail inconvenience and require some adaptation for tens of thousands of British Columbians currently using Lantus and their prescribing physicians.  Patients and prescribers can rest assured that Basaglar has the same effectiveness and time release pattern, unit for unit, as Lantus.”

Dr. Brian Bressler, gastroenterologist, director, Advanced IBD Training Program, clinical associate professor, St. Paul’s Hospital –

“I was happy to be consulted on this decision, and I look forward to continuing to work with the provincial government on ways to improve care in a cost-effective manner for those living with IBD.”

What are biosimilars?
  • Biosimilars are highly similar versions of bioengineered drugs, known as biologics. Biologics are expensive, injectable drugs made from living organisms (e.g., bacteria or yeast) and are used to treat a growing number of diseases, from cancer to chronic conditions including arthritis, diabetes and Crohn’s and ulcerative colitis.
  • Once patents for biologic drugs expire (20 years after the patent was filed), other manufacturers can bring biosimilars on to the Canadian market, in a similar way to generic drug manufacturers.
  • Since biosimilars are based on work done to develop the original biologic drug, they require less research and development.
  • This means the biosimilar can be priced lower than the biologic – anywhere from 25% to 50% less – providing the same health benefits, for better value.
  • Biosimilars are approved for sale just as any other drug. In fact, Health Canada will not approve a biosimilar for sale unless it is proven to have no clinically meaningful difference to the patient compared to the original biologic drug.
  • Similarity between biologics and biosimilars is demonstrated using a step-wise approach beginning with structural and functional studies and continuing with human clinical trials and are evaluated to confirm that there are no clinically meaningful differences in safety and efficacy between them. 
  • There are currently 10 biosimilars approved for sale in Canada, nine in the U.S. and 15 in the E.U.
What other countries are doing with biosimilars

The Patented Medicines Price Review Board has provided the following data on 2018 infliximab biosimilar use rates for Organisation for Economic Co-operation and Development countries.

Infliximab treats rheumatoid arthritis, psoriatic arthritis, plaque psoriasis and Crohn’s disease and ulcerative colitis. The legacy or reference biologic is called Remicade and the two biosimilars currently available in Canada are called Inflectra and Renflexis.

  • Norway - 98%
  • Poland - 96%
  • UK - 92% 
  • Austria - 89%
  • Italy - 79%
  • Sweden - 78%
  • Slovenia - 64%
  • Portugal - 63%
  • France - 60%
  • Czech Republic - 59%
  • Spain - 56%
  • Germany - 53%
  • Ireland - 40%
  • Korea - 37%
  • Slovakia - 36%
  • Belgium - 30%
  • Turkey - 23%
  • Switzerland - 22%
  • Mexico - 17%
  • Finland - 17%
  • Australia - 16%
  • Japan - 9%
  • Canada - 8%
  • USA - 7%
  • Chile - 0%
  • Hungary - 0%
  • New Zealand - 0%

Data source: MIDAS Database, prescription retail and hospital markets, Q4-2018, IQVIA.

Rising cost of biologics
  • According to the Patented Medicines Price Review Board, seven of the top 10 selling drugs in Canada in 2016 were biologics. In addition, there are 13 biologics that have expired patents – or patents that will expire – by 2020. This will allow manufacturers to submit biosimilars for market authorization. Since there is a much higher use of biologics in Canada, it means that Canadians have the most to gain from biosimilar savings. Source: https://www.cadth.ca/sites/default/files/symp-2017/presentations/april24-2017/Concurrent-Session-B4-Gary-Warwick.pdf
  • According to 2018 data from the Canadian Institute for Health Information, $14.4 billion of prescribed drug spending (42.7%) was financed by the public sector. Biologics used to treat conditions like rheumatoid arthritis and Crohn’s disease accounted for the highest proportion of public drug spending (8.2%) for the sixth consecutive year. Canadians with drug costs of $10,000 or more represented 2% of beneficiaries but accounted for more than one-third of public drug spending in 2017. Source: https://www.cihi.ca/en/health-spending/2018/prescribed-drug-spending-in-canada
  • In addition, as of September 2018, there are seven biosimilars available in Canada, and their uptake has been modest. For example, infliximab and etanercept biosimilars accounted for 2.4% of claims and 1.4% of spending in 2017. Source: https://www.cihi.ca/sites/default/files/document/pdex-report-2018-en-web.pdf
  • According to the Canadian Agency for Drugs and Technologies in Health, many of the top selling biologic drugs already have or are expected to have biosimilars enter the market within the next few years. The European experience shows that increased biosimilar competition has not only affected the prices of the directly comparable biosimilars and their reference product, but also of the whole product class. Source: https://cadth.ca/sites/default/files/pdf/ES0317_biosimilars.pdf

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