Provincial and Territorial Biologics Policies
To learn more about biologics and biosimilars, including how biologic medications work in the body and which biologic and biosimilar medications are available in Canada, click here.
The situation in Canada for originator biologic and biosimilar policy is rapidly changing. Here is the current status, as at August 2024.
| Biologics Policies | Jurisdiction |
| originator / biosimilar have the same listing status and reimbursement criteria | NIHB |
| preferential access for biosimilars (naive patients) | PE, NU, FPDBP |
| grandfather clause (existing patients) | MB, ON, QC, YT |
| lowest cost alternative listing | QC |
| preferential access for biosimilars (naive patients) / non-medical switching policy (existing patients) | BC, AB, SK, MB, ON, QC, NB, NL, NS, PE, NT |
| biologics tiering | AB |
Biosimilars Switch Policy Implementation by Jurisdiction
| Jurisdiction | Date |
| British Columbia | May 2019 |
| Alberta | January 2021 (revised due to the COVID-19 pandemic) |
| Saskatchewan | October 2022 |
| Manitoba | N/A |
| Ontario | March 2023 |
| Quebec | July 2021 |
| New Brunswick | April 2021 |
| Nova Scotia | February 2022 |
| Prince Edward Island | October 2023 |
| Newfoundland and Labrador | March 2023 |
| Yukon | April 2023 |
| Northwest Territories | December 2021 |
| Nunavut | N/A |
| Federal Public Drug Programs | N/A |
Policy Implementation Details
| Jurisdiction | Status |
| BC1 | Phase 1: Non-medical switching policy announced on 2019-05-27 for Enbrel® (etanercept), Lantus® (insulin glargine), and Remicade® (infliximab) (affected indications are diabetes, psoriasis, and rheumatic diseases.
Phase 2: On 2019-09-05 the non-medical switching policy was expanded to Remicade® (infliximab) for inflammatory bowel diseases (Crohn’s disease and ulcerative colitis). All those receiving the applicable originator biologics are required to switch to a biosimilar or BC PharmaCare will not pay. Phase 3: On 2020-08-20 the government expanded their switching policy to Rituxan® (rituximab) for granulomatosis with polyangiitis, microscopic polyangiitis, relapsing-remitting multiple sclerosis (MS), and rheumatoid arthritis. Those currently taking Rituxan® (rituximab) will need to switch to biosimilars TruximaTM, RiximyoTM, and RuxienceTM by 2021-02-18 if they want PharmaCare coverage. Note that Health Canada did not approve the innovator rituximab biologic for the treatment of MS. Yet, the BC government is mandating a switch for people with this condition to the rituximab biosimilars mentioned above. Phase 4: On 2021-04-07, individuals on Humira® (adalimumab) must switch to one of five biosimilars before 2021-10-06. These biosimilars are AmgevitaTM, HadlimaTM, Hulio®, Hyrimoz®, and Idacio®. Individuals with plaque psoriasis on Enbrel® (etanercept) also need to switch to its biosimilars Brenzys® and Erelzi®. In 2019, the BC Cancer Agency implemented an Oncology Biosimilars Utilization Policy. Individuals starting new treatment on bevacizumab, trastuzumab, and rituximab will only receive coverage for its biosimilar versions.2 The policy also supports off-label use of biosimilars (e.g., bevacizumab for cervical cancer), which means physicians can prescribe biosimilars for indications that have not received Health Canada approval. |
| AB3 | The Alberta government announced a non-medical switching policy effective on 2021-01-14 (revised due to the pandemic). Individuals living with ankylosing spondylitis, Crohn’s disease, diabetes (Type 1 and 2), multiple sclerosis, neutropenia, psoriasis, psoriatic arthritis, rheumatoid arthritis, and ulcerative colitis on originator biologic therapies must switch to a biosimilar. Alberta Blue Cross also delisted originator biologics on 2021-01-15. However, an exception process is in place (similar to BC).
On 2021-05-01, Alberta Blue Cross added Humira® (adalimumab) and Lovenox® (enoxaparin) in their non-medical switching policy, with a deadline to switch before 2022-05-01. Individuals under the age of 18 years old and pregnant women are exempt from the biosimilars policy. |
| SK4 | SK is leading the pCPA Governing Council and is the sixth jurisdiction to implement a non-medical switching policy, effective 2022-10-20. This policy affects several medications in the public drug plan, and it will grow as more biosimilars for reference biologics become available. Individuals with conditions such as diabetes, psoriasis, rheumatoid arthritis, and inflammatory bowel disease (IBD) will need to switch to a biosimilar version by 2023-04-30.
There will be an exception process available on a case-by-case basis. Individuals who would not like to switch based on a medical reason will need to meet with their treating physician, who will submit the request on their behalf. The Ministry specified that biosimilar products are not interchangeable.5 |
| MB6 | Effective August 1, 2024, individuals must switch to a biosimilar version of their medication, if applicable, to maintain public drug coverage. The deadline to switch is January 31, 2025.7 Pharmacare considers exceptions on a case-by-case basis. Your prescriber needs to submit a request on your behalf. |
| ON8 | On 2022-12-20, the ON Ministry of Health announced their biosimilars switching policy. The implementation date starts on 2023-03-31 and ends on 2023-12-29. Individuals receiving coverage for originator biologics under the Ontario Drug Benefit program will have nine months to switch to a biosimilar.
Currently, this policy affects the following biologics: Copaxone® (glatiramer acetate), Enbrel® (etanercept), Humira® (adalimumab), Lantus® (insulin glargine), NovoRapid® (insulin aspart), Remicade® (infliximab), and Rituxan® (rituximab). This list will likely expand as more biosimilars for originator biologics become available in Canada. The Ministry will consider exemptions on a case-by-case basis. Individuals who would not like to switch based on a medical reason will need to meet with their treating physician, who will submit the request on their behalf. |
| QC | INESSS published a report in May 2020 studying the safety and effectiveness of switching between originator biologics and biosimilars.9 They concluded that there is very little evidence to show that switching is safe, especially in people with inflammatory bowel disease (Crohn’s disease and ulcerative colitis) or cancer. Clinicians also have serious concerns with a non-medical switch. The Quebec government will incorporate this report in its biosimilars policy.
On 2021-02-19, the Gastrointestinal Society met with RAMQ to discuss their biosimilars policy. MSSS announced a non-medical switch policy with exceptions requiring that individuals have until 2022-04-13 to switch to a biosimilar of their reference biologic, with the support of their healthcare team.10 Several medications are affected. Exceptions to the policy apply to pregnant women, who must switch to a biosimilar 12 months after giving birth, and those under 18 years old. Once they turn 18, they have 12 months until they need to switch to a biosimilar. Those who have experienced two or more treatment failures are also exempt and do not need to switch. On 2021-04-15, the government implemented changes to copay cards, prohibiting manufacturers, wholesalers and intermediaries from paying any portion of a drug that is covered by the province.11 There are some exceptions to this The Ministry will continue to have discussions with stakeholders on this policy and information and resources will be made available for healthcare professionals and individuals. |
| NB12 | New Brunswick Medicare announced a non-medical switching policy on 2021-04-21 halting coverage for the following originator biologics: Humira® (adalimumab), Enbrel® (etanercept), Remicade® (infliximab), Lantus® (insulin glargine), Humalog® (insulin lispro), Rituxan® (rituximab), and Copaxone® (glatiramer). To maintain coverage, individuals must switch to a biosimilar by 2021-11-30 or on the renewal date of their special authorization approval, if it is earlier. Those on Lovenox® (enoxaparin) to treat thromboembolic events must switch to a biosimilar by 2022-02-28. Those who need to continue on the originator biologic for medical reasons can apply for exceptional request with their treating physician. Talk to your doctor about your options. |
| NL | The Newfoundland and Labrador Prescription Drug Program (NLPDP) announced a non-medical switching policy on 2023-03-24.13 Individuals who are on a reference biologic must switch to a biosimilar by 2024-04-01.
Individuals can choose a biosimilar product to switch to if there is more than one available for the biologic. Pregnant women can switch to a biosimilar after they have given birth.14 Also, those using an insulin pump that is not compatible with biosimilar insulins do not need to switch and can continue to receive coverage. |
| NS | The Nova Scotia Pharmacare Programs grants preferential access to biosimilars for individuals new to biologic therapy. Nova Scotia Pharmacare invited the Biosimilars Working Group (biosimilaroptions.ca), of which we are a member, to discuss the impact of biosimilar policies.
On 2022-02-04, Nova Scotia Pharmacare announced a non-medical switching policy effective immediately.15 Residents on originator biologics have 12 months to switch to a biosimilar. Those who wish to continue the originator can apply for exemptions. |
| PE | By 2024-06-30, individuals on originator biologics must switch to a biosimilar to maintain coverage through PEI Pharmacare.16
Due to the ongoing healthcare crises, a switching exception form is available for those who are unable to meet with their healthcare provider before the deadline to switch. However, the form will only extend the coverage for your biologic drug for one month. At the latest, individuals affected by the policy must have an appointment scheduled with their doctor before 2024-09-30. Pregnant women and those who are using an insulin pump that is not compatible with a biosimilar version are exempt from the switching policy. Your healthcare provider must complete and submit an exemption form on your behalf. |
| Territories | Yukon17 and Nunavut18 grants preferential access for biosimilars.
The Government of the Northwest Territories launched a Biosimilars Initiative, effective on 2021-12-21.19 Individuals on originator biologics have until 2022-06-20 to switch to a biosimilar to maintain public coverage. Those new to biologic therapy will only receive coverage for the biosimilar. |
| Federal Public Drug Programs | The federal government has several programs that provide coverage for biologic therapies for the First Nations and Inuit, members of the Canadian Armed Forces, and veterans.
Under the Non-Insured Health Benefits (NIHB) program for First Nations and Inuit, there are fewer originator biologics and biosimilars available compared to provincial drug plans, but they have the same terms of coverage.20 The Canadian Forces Drug Benefit Plan (CFDBP) covers biosimilars for people who are new to biologic therapy. Those who are receiving originator biologics can continue their treatment and receive coverage.21 The Treatment Benefits Program of Veterans Affairs Canada requires special authorization approval for the coverage of originator biologics and biosimilars.22 |
INESSS: Institut national d’excellence en santé et en services sociaux; MSSS: Ministère de la Santé et des Services sociaux; NBPDP: New Brunswick Prescription Drug Program; pCPA: pan-Canadian Pharmaceutical Alliance; FPDBP: Federal Public Drug Benefit Programs.
*Copaxone® (glatiramer acetate) is not a biologic but several provincial drug programs have included it under their biosimilars policy.
References
1. BC Pharmacare Biosimilars Initiative. Biosimilars Initiative for Prescribers. Available at: https://www2.gov.bc.ca/gov/content/health/practitioner-professional-resources/pharmacare/prescribers/biosimilars-initiative-prescribers.
2. BC Cancer. Biosimilar Drugs page. Available at: http://www.bccancer.bc.ca/health-professionals/clinical-resources/biosimilar-drugs.\
3. Alberta Blue Cross. Government-sponsored Biosimilar Initiative. Available at: https://www.ab.bluecross.ca/resources/government-programs/biosimilar-initiative.php.
4. Saskatchewan Launches Biosimilars Initiative. Saskatchewan. Available at: https://www.saskatchewan.ca/government/news-and-media/2022/october/20/saskatchewan-launches-biosimilars-initiative.
5. Saskatchewan Formulary Bulletin. 2021-06-01. Available at: https://formulary.drugplan.ehealthsask.ca/Bulletins/Bulletin-0200-Jun-2021.pdf.
6. Information for Health Professionals. Available at: https://www.gov.mb.ca/health/pharmacare/healthprofessionals.html.
7. Manitoba Biosimilars Initiative. Government of Manitoba. 2024-08-02. Available at: https://www.gov.mb.ca/health/pharmacare/biosimilars.html.
8. Ontario Expanding Safe Use of Biosimilars. Government of Ontario. 2022-12-20. Available at: https://news.ontario.ca/en/release/1002611/ontario-expanding-safe-use-of-biosimilars.
9. Innocuité de la substitution et de l’interchangeabilité des médicaments biologiques. Institut national d’excellence en santé et en services sociaux. 2020-06-01. Available at: https://www.inesss.qc.ca/publications/repertoire-des-publications/publication/innocuite-de-la-substitution-et-de-linterchangeabilite-des-medicaments-biologiques.html.
10. Biosimilar Drugs. Available at: https://www.quebec.ca/en/health/medications/biosimilar-drugs.
11. Know the conditions for coverage. Available at: https://www.ramq.gouv.qc.ca/en/citizens/prescription-drug-insurance/know-conditions-coverage.
12. Government of New Brunswick. Biosimilars Initiative. Available at: https://www2.gnb.ca/content/gnb/en/departments/health/MedicarePrescriptionDrugPlan/NBDrugPlan/biosimilars.html.
13. Public Advisory: Newfoundland and Labrador Expanding Safe Use of Biosimilars. 2023-03-24. Available at: https://www.gov.nl.ca/releases/2023/health/0324n04/.
14. Newfoundland Labrador. Special Authorization Drug Products. Available at: https://www.gov.nl.ca/hcs/prescription/covered-specialauthdrugs/.
15. Nova Scotia Moving to Biosimilar Drugs for Pharmacare Programs. Nova Scotia. Available at: https://novascotia.ca/news/release/?id=20220204002.
16.Biosimilar Initiative. Available at: https://www.princeedwardisland.ca/en/service/pei-biosimilar-initiative.
17. Find Drug Coverage Information. Yukon. Available at: https://yukon.ca/en/health-and-wellness/medical-professionals/find-drug-coverage-information.
18. NHB Full Coverage Plan. Nunavut Department of Health. Available at: https://gov.nu.ca/health/information/ehb-full-coverage-plan.
19. Biosimilar Initiative. Government of Northwest Territories. Available at: https://www.hss.gov.nt.ca/en/services/biosimilar-initiative.
20. Non-Insured Health Benefits: Drug Benefit List. Government of Canada. Available at: https://www.sac-isc.gc.ca/eng/1572888328565/1572888420703#s4a.
21. Canadian Armed Forces Drug Benefit List. Government of Canada page. Available at: http://www.cmp-cpm.forces.gc.ca/hs/en/drug-benefit-list/index.asp.
22. Drug Formulary Search Form. Veterans Affairs Canada page. Available at: https://www.veterans.gc.ca/eng/financial-support/medical-costs/treatment-benefits/poc10/search.