Government of New Brunswick


The New Brunswick Department of Health launched a Biosimilars Initiative in 2021 which involves switching patients from originator biologic drugs to their biosimilar versions. It 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 improve access to drugs for patients.

Biologics represent some of the largest drug expenditures for the New Brunswick Drug Plans. Increasing the use of biosimilars provides savings that will be used to cover new drugs and contribute to the sustainability of the public drug plans.

Patients who use certain originator biologics must switch to a biosimilar brand to maintain their coverage under the New Brunswick Drug Plans. The drugs included in the Biosimilars Initiative and the date by which patients must switch to a biosimilar brand are in the table below. Additional originator biologics will be added when their biosimilar brands are listed as benefits.
 

 

Biologic Drugs Included in the Biosimilars Initiative


Current Switch Period(s)
None

Completed Switches to Biosimilars 

Drug

Originator
(Switch from)

Biosimilar
(Switch to)

Indications

Originator Coverage Ends on May 31, 2022

Insulin aspart

NovoRapid

Trurapi

Diabetes

Originator Coverage Ends on February 28, 2022

Enoxaparin

Lovenox

Redesca
Inclunox
Noromby

Prevention and Treatment of Thromboembolic Events

Originator Coverage Ends on November 30, 2021

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

Glatiramer

Copaxone

Glatect

Multiple Sclerosis

 


Leading regulators in the world, including the European Medicines Agency, the Food & Drug Administration in the United States and Health Canada, support well-controlled transitions to biosimilars. Patients need to know that transition policies have been safely and effectively implemented in many countries in Europe.

Health Canada is responsible for ensuring the safety and efficacy of all new drugs on the market including biosimilars. For a biosimilar to be approved for use in Canada, Health Canada evaluates functional, structural, and clinical studies comparing biosimilars to their originators. Authorized biosimilars are shown to be highly similar to their originators and Health Canada expects no meaningful differences in switching from routine use of an originator biologic to a biosimilar for an approved indication.

There are now more than 100 research studies on biosimilars in rheumatology, gastroenterology, dermatology and other diseases, which collectively show little to no clinical differences between biosimilars and their 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. There is no scientific reason to expect a different clinical outcome, but patient perspectives should be considered.

 


1.    Why was a Biosimilars Initiative implemented?

Biologic drugs account for some of the New Brunswick public drug plans’ largest expenditures. Increasing the use of biosimilars will provide savings that will be used to cover new drugs and contribute to the sustainability of the public drug plans.

2.    Has a Biosimilars Initiative that switches patients been done in other provinces?

Yes. Most provinces in Canada have implemented a Biosimilars Initiative. In addition, biosimilars switching has been performed extensively in Europe, where countries have had over 15 years of experience with biosimilars.

3.    Does switching to a biosimilar impact patient outcomes?

Health Canada’s approval process requires that studies demonstrate no clinically meaningful differences in immunogenicity between the biosimilar and the originator biologic. Health Canada indicates that patients and health care providers can be confident that biosimilars are effective and safe for each of their authorized indications, and that no differences in efficacy and safety are expected following a change in routine use between an originator biologic and its biosimilar in an authorized indication.

4.    What is the process for switching patients?

Prescribers play an important role in the switching process. As a trusted and experienced information source, a prescriber may set the tone of the discussion, facilitate continuity of care, and empower the patient to understand and realize the best outcomes. The following steps may help patients with their switch to a biosimilar.

  • Identify a patient using a biologic included in the Biosimilars Initiative.
  • Discuss switching to a biosimilar with the patient. Appointments may be in-person or virtual (phone or video call).
  • Initiate enrolment in the patient support program for the biosimilar (if applicable).
  • Write your patient a new prescription, indicating the chosen biosimilar.

5.    How do I identify patients using a biologic included in the Biosimilars Initiative?

To assist in identifying patients, prescribers may request a list of their patients who are using a biologic that is included in the initiative by submitting the Patient List Request Form.

6.    Do I need to write a new prescription for a biosimilar?

Yes. After discussing the biosimilar switch with your patient, initiate enrolment in the patient support program (if applicable). Write a new prescription for your patient, indicating the change to the chosen biosimilar.

7.    If the originator biologic requires special authorization (SA), do I need to submit a new request for the corresponding biosimilar?

No, SA requests do not need to be submitted for patients who are switching. When biosimilar brands are listed as benefits, they are added to existing SA approvals.

8.    What if I can’t see patients before the end of the switch period?

If you cannot prescribe a biosimilar for your patients by the end of the switch period, their originator biologic drug will no longer be covered by the New Brunswick Drug Plans. The coverage end date for each biologic is specified in the table above.

9.    What if a patient cannot be switched to a biosimilar?

If a patient is unable to switch for medical reasons, you may submit an SA request for exceptional coverage of the originator biologic. The request must clearly indicate the medical reason why the patient cannot switch. Requests are reviewed on a case-by-case basis.

10.  Which biosimilars are covered?

The originator biologics included in the initiative and the respective biosimilars that are covered by the NB Drug Plans are listed in the table above.

11.  Where can I find more information on biosimilars and switching?

Links to information on biosimilars and studies about switching are listed below under “Additional Information and Studies”.

 


Links to additional information and studies are listed below.

Arthritis Consumer Experts:

Arthritis Research Canada:

Canadian Digestive Health Foundation: Crohn’s Disease

Canadian Digestive Health Foundation: Ulcerative Colitis

General

 


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.