Newfoundland and Labrador Biosimilars Policy
What is Changing in the Newfoundland and Labrador Coverage for Biologics?
The Government of Newfoundland and Labrador is expanding the use of biosimilar drug treatments offered through the Newfoundland and Labrador Prescription Drug Program. Under this initiative, to maintain coverage, patients with inflammatory Bowel Disease (IBD) currently using one of the originator biologics of Humira®, and Remicade® will be transitioned to a safe, effective and less costly biosimilar version on or before March 31, 2024.
This initiative follows similar efforts elsewhere in Canada including Alberta, Quebec, New Brunswick, Northwest Territories, and Ontario. Tens of thousands of Canadians have safely switched to a biosimilar in those initiatives. They are also used extensively in Europe, where countries have had over 15 years of experience with biosimilars.
Program beneficiaries who have been identified as using one or more of these originator biologics will receive a letter which contains additional information, as well as outlining the next steps needed to transition to a biosimilar. The Newfoundland and Labrador Prescription Drug Program will continue to work with partners, including health professionals and manufacturers, to ensure a successful transition.
For information on the Biosimilars Initiative, please visit the Newfoundland and Labrador Prescription Drug Program website.
Biologic Medications Included in the NLPDP Biosimilars Initiative:
When more than one biosimilar option exists for an originator, it is the patient’s choice, in consultation with their health professional, which biosimilar option they will use. Additional originator biologics will be added to the initiative as new biosimilar options are approved by Health Canada and listed as benefits of NLPDP.
|Biologic*||Originator Biologic*||Funded Biosimilar(s)*||Originator coverage end date|
|adalimumab||Humira||Abrilada, Amgevita, Hadlima, Hulio, Hyrimoz, Idacio, Simlandi, Yuflyma||April 1, 2024|
|enoxaparin||Lovenox||Inclunox, Noromby, Redesca, Elonox||April 1, 2024|
|etanercept||Enbrel||Brenzys, Erelzi||April 1, 2024|
|glatiramer||Copaxone||Glatect||April 1, 2024|
|infliximab||Remicade||Avsola, Inflectra, Renflexis||April 1, 2024|
|rituximab||Rituxan||Riximyo, Ruxience, Truxima||April 1, 2024|
CDHF Biosimilar Library
Frequently Asked Questions
1. What is a biologic?
Biologic (reference) drugs are medications made by using living organisms (such as yeast or animal cells) to produce complex proteins that are purified then administered to affect certain processes in the human body.
2. What is a biosimilar?
A biosimilar is a drug demonstrated to be highly similar to a biologic (reference) drug, that has been authorized for sale in Canada.
3. What is the NLPDP Biosimilar Initiative?
NLPDP Biosimilar Initiative is a biosimilars transition policy where beneficiaries using
certain originator biologics will transition to a biosimilar version to maintain coverage.
4. How do I get my prescription changed to a biosimilar? Do I need a new special authorization?
If you have Inflammatory Bowel Disease, and currently use Humira®, or Remicade®
- Your prescriber can assist you with transitioning to a biosimilar no later than your next special authorization reassessment and renewal appointment
- Your next special authorization will be approved for a biosimilar
- Your prescriber can help answer your questions, explain the transition process and write your biosimilar prescription If you are not due to see your prescriber on or before March 31, 2024, You will need to make an appointment to discuss transitioning your medication to a biosimilar and having a new special authorization and prescription completed
5. Why is the change happening?
The Newfoundland and Labrador Prescription Drug Program Biosimilars Initiative provides an evidence-based opportunity to get the best value from medications funded under the program, without negatively affecting patient health outcomes. This will allow the program to invest in new and innovative drug therapies while continuing to expand access to existing drug treatments.
6. Are biosimilars safe and effective compared to the originator biologic drug?
Yes, before a biosimilar drug is approved by Health Canada, the manufacturer must show that there are no meaningful differences in safety and effectiveness compared to the originator version. Patients should expect no difference when transitioning from an originator biologic to its biosimilar version.
CDHF Resource Links
- Explore CDHF’s Biosimilar Library
- CDHFTalks: Your New Infusion Clinic.. Not the Same, but Similar.
- CDHF | Transition Pathway Brochure for IBD Patients
- CDHF | Biosimilars for IBD: Making the Transition Webinar
- CDHF | What’s Health Canada saying about Biosimilars Animation
- CDHF | What’s Health Canada saying about Biosimilars Infographic
- CDHF | IBD: Switching from a Biologic to a Biosimilar Animation