Government of New Brunswick


The New Brunswick Department of Health is launching a Biosimilars Initiative which involves switching patients from originator biologic drugs to their biosimilar versions. This initiative optimizes New Brunswick’s public resources by achieving the best value for new treatments, in order to make the public drug plans more sustainable and to improve patient access to medications. It follows the successful implementations of similar initiatives by British Columbia and Alberta, where tens of thousands of patients were safely switched, including those living with inflammatory arthritis, diabetes, psoriasis and inflammatory bowel disease. In addition, switching to biosimilars has been conducted extensively in Europe, where countries have had over 15 years of experience with biosimilars.

Originator biologic drugs make up some of the New Brunswick Drug Plans’ largest drug expenditures. As the patents for originator biologics expire, other manufacturers are able to produce biosimilar versions at a much lower cost. Even though biosimilars approved by Health Canada are proven to be as safe and effective as the originators, the uptake in Canada of biosimilars continues to be very low.

The Biosimilars Initiative involves switching New Brunswick Drug Plans’ patients from certain originator biologics (listed in the table below) to the biosimilar versions. Between April 21, 2021 and November 30, 2021, both the originator biologic drug and biosimilar versions will be covered to allow time for patients to consult their prescribing physician and initiate the switching process. Coverage of the originator biologics will end on November 30, 2021 or on the renewal date of the patient’s special authorization approval for the originator biologic under the New Brunswick Drug Plan, whichever is sooner. Insulin glargine, insulin lispro and glatiramer are regular benefits so special authorization is not required. 
 

 

Biologic Drugs Included in the Biosimilars Initiative

 

Drug

Originator
(Switch from)

Biosimilar
(Switch to)

Indications

Adalimumab

Humira®

Idacio®
Amgevita™
Hadlima®
Hyrimoz®
Hulio®

Ankylosing Spondylitis
Plaque Psoriasis
Psoriatic Arthritis
Rheumatoid Arthritis
Crohn's Disease
Ulcerative Colitis
Polyarticular Juvenile Idiopathic Arthritis
Hidradenitis Suppurativa
Non-Infectious Uveitis

Etanercept

Enbrel®

Brenzys®
Erelzi®

Ankylosing Spondylitis
Plaque Psoriasis
Psoriatic Arthritis
Polyarticular Juvenile Idiopathic Arthritis
Rheumatoid Arthritis

Infliximab

Remicade®

Inflectra®
Renflexis™
Avsola™

Ankylosing Spondylitis
Plaque Psoriasis
Psoriatic Arthritis
Rheumatoid Arthritis
Crohn's Disease
Ulcerative Colitis

Insulin glargine

Lantus®

Basaglar™

Diabetes

Insulin lispro

Humalog®

Admelog®

Diabetes

Rituximab

Rituxan®

Ruxience™
Truxima™
Riximyo®

Rheumatoid Arthritis
Vasculitis
Autoimmune Diseases

Glatiramer1

Copaxone®

Glatect™

Multiple Sclerosis

1Non-biologic complex drug

 

Health Canada monitors the safety of all drugs on the market, including biosimilars. Both non-clinical and clinical studies compare a biosimilar version to its originator version. Before a biosimilar can be used in Canada, Health Canada also assesses its immunogenicity. Immunogenicity is how a body’s immune system reacts to the drug. Health Canada finds no meaningful differences between biosimilars and their originator versions and supports the switch from routine use of an originator to its biosimilar version for approved medical conditions.

Patients should switch to the biosimilar version of their originator biologic by November 30, 2021 if they want continued coverage through the New Brunswick Drug Plans. After November 30, 2021, the originator biologic will not be covered without an approved exceptional request. For some patients, it may be medically necessary to continue using the originator biologic. To receive coverage for the originator version after November 30, 2021, your prescriber must determine the medical requirement and request exceptional special authorization approval. Exceptional requests are reviewed on a case-by-case basis.
 


Biologic drugs (originators and biosimilars) are created from living organisms like yeast and bacteria. Biologics are used to treat patients with a range of different conditions, including diabetes, autoimmune diseases, cancer and other serious diseases. The first version of a biologic developed is known as the originator. This is because they are the original version of a biologic drug which a biosimilar version is based on.

As patents expire for originator biologics, other manufacturers may produce new versions. These new versions are called biosimilar biologics. Since biologic drugs are large and complex, biosimilars are highly similar, though not identical, to the originator version. Many studies have compared biosimilars to their originator versions and have shown no meaningful differences in safety or efficacy. Originator biologics have already set the foundation of research and development for biosimilars, which means biosimilars are more cost-effective to produce and lead to similar outcomes.

Even within different production batches of the same originator brand biologic, there are small differences between them. This is because they are made using living organisms with some inherent variability. The same goes for the slight differences between a biosimilar biologic and its originator biologic, which are also not clinically meaningful. Biosimilars are being used extensively to treat diabetes, autoimmune diseases such as inflammatory arthritis, psoriasis and inflammatory bowel disease.
 


If you are using a biologic that is included in the Biosimilars Initiative:

  • Make an appointment with your prescriber that will occur before November 30, 2021
  • Discuss the switch with your prescriber
  • Your prescriber can explain the switching process, discuss your biosimilar options, and write you a new prescription
  • Ensure you switch before the end of the switch period in order to maintain your continued coverage by the New Brunswick Drug Plans.

By switching to a biosimilar, you are helping to save millions of dollars every year. This is an opportunity to maximize resources to make the New Brunswick Drug Plans more sustainable, expand coverage for new treatments and improve patient access to more medications.
 

 
1. What is a biologic? What is a biosimilar?

Biologic drugs (originators and biosimilars) are made using living organisms (e.g., yeast or animal cells) rather than being synthetically manufactured. This class of drugs is designed to treat various conditions by affecting certain processes within the body.

When patents for originator biologics expire, other manufacturers may produce biosimilar versions. Biosimilar biologics are not identical to originator biologics due to their complex structure. However, biosimilars are highly similar to the originator and are tested to ensure the same health outcomes and level of safety.

2. What are the benefits of biosimilars?

Although biologics help treat patients with serious diseases, they are complex drugs and can be very expensive and time consuming to develop. Therefore, access to these medications is limited and it is difficult for the healthcare system to afford originator versions.

Since biosimilars are developed based on a foundation of biologic work, they are less expensive to produce, do not compromise efficacy and safety, and lead to major cost savings that can be reinvested into our healthcare system. A healthy and competitive drug market can support diverse manufacturers to produce new and affordable drugs.

3. What are the experts saying? Are biosimilars safe?

Health Canada is responsible for ensuring the safety, efficacy, and quality of all new drugs including biologics (originators and biosimilars). Before a biosimilar drug can be approved in Canada, Health Canada must have found no meaningful differences in safety and effectiveness compared to the originator version. The biosimilars involved in the Biosimilars Initiative have all been approved by Health Canada.

4. Do I have to switch to a biosimilar?

Yes, if you are covered by the New Brunswick public drug plans and using any of the originator biologics in the table above. You will need to switch to the biosimilar version before the end of the switch period in order to avoid any disruption to your coverage.

5. Will a biosimilar work for me?

Though a biosimilar biologic is not identical to an originator biologic, there are no clinically meaningful differences between them. A biosimilar drug delivers similar effectiveness, level of safety, and the same therapeutic benefits to patients. Health Canada assures patients and health professionals that biosimilars are safe and effective. Moreover, Health Canada expects no differences following a change in routine use between an originator and its biosimilar for diseases they are approved to treat.

Ask your prescriber about your options based on your medical background and what the differences are between the available medications.

6. What is the nocebo effect and how can I prevent it?

The nocebo effect occurs when a patient’s negative expectations affect the treatment outcomes. A patient’s mindset can impact their symptoms and their sense of wellbeing. Factors that can contribute to experiencing the nocebo effect are: mental health issues, language barriers, relying on unbalanced online media as an information source, negative interactions with healthcare professionals and settings, etc.

To address a possible nocebo effect, you can:

  • Acknowledge the nocebo effect
  • Seek out more information on biosimilars (see the Resources section below)
  • Speak to your prescribing doctor or pharmacist about the switch and discuss your options
  • Stay informed about the switch process
  • Keep a neutral or positive outlook

7. What if I can’t switch to a biosimilar?

There may be exceptions where some patients cannot switch to a biosimilar biologic for exceptional medical reasons. Your prescriber can help you determine why it is medically necessary to remain on an originator biologic. A special authorization request may then be submitted by the prescriber to consider approval for continued coverage of an originator biologic.

8. I take Remicade® or Rituxan®, which are biologics that are administered through an infusion. If I switch to the biosimilar, do I have to go to a different infusion centre?

As part of the biosimilar switch, you may switch to a new infusion centre to receive your infusion of the biosimilar version. The patient support program offered by the manufacturer of the biosimilar version will coordinate this change.

9. What are patient support programs?

Patient support programs are available to help patients switching to most of the biosimilars in the Biosimilars Initiative. These programs are supplied by the manufacturers of the biosimilars. Information on patient support programs and infusion clinics is available online.

10. What if I have private coverage?

If you do not rely on New Brunswick Drug Plans for coverage of your originator biologic, the Biosimilars Initiative will not directly affect you. However, as some private insurers offering employer-sponsored plans have also been implementing biosimilar switch policies, you may wish to contact your private insurer for more information.

11. Can switching be done during COVID-19?

Yes, as the Department of Health has introduced temporary virtual care options, so patients may not need to physically go to a doctor’s office.
 

 

Contact Information


If you have any questions about the Biosimilars Initiative, contact the NB Drug Plans.

Phone: 1-800-332-3691, Monday to Friday, 8am to 5pm

Email: info@nbdrugs-medicamentsnb.ca.