Biosimilars Initiative

The New Brunswick Department of Health has launched a Biosimilars Initiative which involves switching patients from originator biologic drugs to their biosimilar versions. It follows the successful implementations of similar initiatives by British Columbia and Alberta. In addition, switching to biosimilars has been conducted extensively in Europe, where countries have had over 15 years of experience with biosimilars.

The Biosimilars Initiative is a result of the New Brunswick Drug Plans’ evidence-informed strategy to better optimize our public resources, get the best value for new treatments and services, and improve access to medications for patients. Increasing the uptake of other biosimilars will provide savings that will be used to cover new drugs and contribute to the sustainability of the public drug plans.

Originator biologic drugs make up some of New Brunswick Drug Plans’ largest drug expenditures, and their costs are growing at an unsustainable rate. In 2019-20, New Brunswick Drug Plans’ spending on biologic drugs grew by 19% to $63.8 million. In the same year, biologic drugs accounted for 29.4% of drug costs but only represented 1.5% of the total number of claims.

Between April 21, 2021 and November 30, 2021, patients who use certain originator biologics (listed in the table below) must switch to a biosimilar brand to maintain their coverage under the New Brunswick Drug Plans. During this period, both the originator biologic and its biosimilar versions will be covered to allow prescribers and patients time to discuss treatment options and to switch patients to a biosimilar.
 

Biologics are drugs made in, taken from or partly-made from living cells through a complex manufacturing process. The first version of a biologic drug is called an originator biologic drug but may also be called an innovator or reference biologic.

A biosimilar drug, or biosimilar, is a biologic drug that is very similar to but less expensive than its originator biologic drug. Biosimilars become available after the patent on the originator biologic drug expires. There are no expected differences in efficacy and safety between a biosimilar and the originator biologic drug.

Health Canada has indicated that no differences are expected in efficacy and safety following switching from an originator biologic to its biosimilar for an authorized indication.
 

¹Non-biologic complex drug

 

How biosimilars are evaluated and approved for sale in Canada

• Biosimilars are approved for sale just as any other drug - they must be evaluated and approved by Health Canada.
• Health Canada will not approve a biosimilar for sale unless it is proven to have no clinically meaningful difference to the patient, as compared to the original biologic drug.
• Biosimilars approved in Canada must be shown to be highly similar to their originators. Health Canada expects no meaningful differences in switching from routine use of an originator drug to a biosimilar for an approved indication.

Switching to a biosimilar

• There are now more than 75 research studies on biosimilars in rheumatology, gastroenterology, dermatology and other diseases, which collectively show little to no clinical differences between biosimilars and their biologic originators, either when used with treatment-naïve patients, or for patients switching to a biosimilar. The majority of switching studies also found that efficacy loss associated with switching to biosimilars was the same as is expected for patients who remain on the originator drug.
• A systematic literature review published in 2018 examined switching from a biologic to a biosimilar. This review included 90 studies with 14,225 patients involving seven molecules in the treatment of 14 diseases. The cumulative results of these studies did not show any significant differences in safety, efficacy or immunogenicity after switching compared to patients who were not switched.
• Due to the complexity of biologic drugs and the natural variability that results from using living cells to make them, it is not possible for a biosimilar to be identical to its biologic. It is also not possible for different batches of an originator biologic drug to be identical. These variations do not affect the drug’s effectiveness.
• Switching can be done safely during COVID-19 as the Department of Health has introduced temporary virtual care options, so patients may not need to physically go to a doctor’s office.

What other jurisdictions are doing with biosimilars

• In 2019, British Columbia and Alberta implemented Biosimilars Initiatives to switch patients from originator biologics to their biosimilars. Tens of thousands of patients in each province were safely switched, including those living with inflammatory arthritis, inflammatory bowel disease, diabetes and psoriasis. British Columbia launched additional phases of their policy in recent months.
• Many European nations have policies that involve switching patients from originator biologics to biosimilars. As a result, the use of biosimilars in many European countries is much higher than in Canada.
• The federal government’s Patented Medicines Price Review Board has provided the following data on the infliximab biosimilars use rates for Organisation for Economic Co-operation and Development countries in 2018. The usage rates below reflect the extent to which biosimilars are used in each’s countries overall infliximab market.
   

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

"The government's initiative to increase the use of biosimilars makes sense, as the resulting savings have been guaranteed to stay in the public drug plans to fund new drugs. Biosimilars are just as safe and effective as the originator versions, as demonstrated by the experiences in British Columbia, Alberta and Europe."

Dr. Mark MacMillan, Gastroenterologist and Assistant Professor in Division of Digestive Care & Endoscopy at Dalhousie University Department of Medicine
 

"Persons with diabetes have been switching to the biosimilar version of their insulin, and many in the province have done so already.  Diabetes care of these people has continued with safety and efficacy.  Prescribers and patients can feel comfortable with treatment with their biosimilar."

Dr. Michael Pelkey, Endocrinologist and Assistant Professor in Division of Endocrinology & Metabolism at Dalhousie University Department of Medicine
 

“Today’s announcement is an important step towards evidence-based sustainable health care. We applaud the New Brunswick government for implementing a policy to increase the use of biosimilars, which have been proven to work just as well as originator biologics. There is a large body of research and experience with biosimilars supporting this change, and similar transition policies have been safely and successfully implemented in British Columbia, Alberta and many European countries. The savings offered by transition to biosimilars help to protect the sustainability of drug plans, and to permit funding of new biologics entering the market. This is good for the people of New Brunswick.” 

Dr. Diane Lacaille, Rheumatologist and Scientific Director of Arthritis Research Canada
 

“As the leader of Canada’s largest arthritis patient organization, I hear every day about disparities in patient access to reimbursement for treatment and services they and their rheumatologist feel they need. Today’s announcement addresses this issue in New Brunswick by ensuring continued reimbursement coverage for patients who transition to a biologic biosimilar and potentially greater access to all advanced therapies (like biologics) for patients in need. Based on the experience in British Columbia and Alberta where thousands of patients have been successfully transitioned, we encourage the New Brunswick government to work with chronic disease communities to identify where reinvestment of biosimilars savings can improve sustainability by adding new medication listings, boost existing medicine coverage and modernize models of care for patients. The key for patients transitioning to biosimilars is understanding the rationale for it and the well-established safety and efficacy of Health Canada approved biosimilars during their treatment options conversations with their specialists. To help patients in New Brunswick, ACE has the latest biosimilar information on our Biosim•Exchange.”

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

“The transition to a biosimilar can take place safely under the right conditions, improve access to treatment while also providing savings that can be reinvested into expanded healthcare. The Arthritis Society’s priority is to ensure that people living with arthritis have access to the life-changing treatments and information they need. We are supportive of the New Brunswick government’s biosimilars initiative announced today and look forward to working with them to ensure that this transition is seamless for patients and puts their needs and experiences front and centre.”

Jone Mitchell, Executive Director of the Atlantic Region for the Arthritis Society