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 April 2020.

Provincial Biologics Policies Provinces
originator / biosimilar have the same listing status and reimbursement criteria PEI4, SK9,10, NS5
preferential access for biosimilars (naive patients) ON14, QC8, MB12, NS (infliximab and etanercept only)5, NB6, NL7, PEI4, YT15, NU17, NT16
grandfather clause (existing patients) YT15, MB, QC
lowest cost alternative listing (infliximab only) QC8
preferential access for biosimilars (naive patients) / non-medical switching policy (existing patients) BC1, AB2
biologics tiering MB11, AB3

Province Status Update
BC1 1.     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. Note: Enbrel® (etanercept) for psoriasis is not required to switch at this time).

2.     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 applicable originator biologic patients are required to switch to a biosimilar or BC PharmaCare will not pay.

AB2,3 Non-medical switching policy announced on 2019-12-12 for Copaxone® (glatiramer acetate injection), Enbrel® (etanercept), Lantus® (insulin glargine), Neulasta® (pegfilgrastim), Neupogen® (filgrastim), and Remicade® (infliximab), with policy implementation by 2021-01-14 (revised due to COVID-19 pandemic). The affected indications are ankylosing spondylitis, Crohn’s disease, diabetes (Type 1 and 2), multiple sclerosis, neutropenia, psoriasis, psoriatic arthritis, rheumatoid arthritis, and ulcerative colitis. Originators will be delisted on 2021-01-15. An exception process is in place (similar to BC). HUMIRA® (adalimumab) is under a tiering policy for rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, Crohn’s disease, and psoriasis.
SK No non-medical switching, but SK is leading the pCPA Governing Council.
MB11 Tiering policy in place for various therapies to treat ankylosing spondylitis, Crohn’s disease, psoriasis, psoriatic arthritis, rheumatoid arthritis, and ulcerative colitis.
ON13 On 2019-11-22, the ON Minister of Health publicly announced that the Ministry will launch a stakeholder consultation on a biosimilars policy.
QC MSSS consultation is currently taking place (postponed).
Atlantic NBPDP consultation is currently taking place (postponed).


MSSS: Ministère de la Santé et des Services sociaux; NBPDP: New Brunswick Prescription Drug Program; pCPA: pan-Canadian Pharmaceutical Alliance.

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. Alberta Blue Cross. Government-sponsored Biosimilar Initiative. Available at: https://www.ab.bluecross.ca/government-plan/biosimilar-initiative.php.
  3. Alberta Government. Bulletin Alberta Health Care Insurance Plan. Available at: https://open.alberta.ca/dataset/58a224a2-0fed-4b1e-b8d5-9f6cf70450c6/resource/e1b64975-8b54-4f1a-8f80-275548bf18a5/download/health-ahcip-bulletin-med-208-2019.pdf.
  4. Prince Edward Island. PEI Pharmacare Formulary. Available at: https://www.princeedwardisland.ca/en/information/health-pei/pei-pharmacare-formulary.
  5. Nova Scotia. Nova Scotia Pharmacare. Available at: https://novascotia.ca/dhw/pharmacare/exception-status-drugs.asp.
  6. New Brunswick. New Brunswick Drug Plans Formulary. Available at: https://www2.gnb.ca/content/gnb/en/departments/health/MedicarePrescriptionDrugPlan/NBDrugPlan/ForHealthCareProfessionals/NewBrunswickDrugPlansFormulary.html.
  7. Newfoundland Labrador. Special Authorization Drug Products. Available at: https://www.health.gov.nl.ca/health/prescription/covered_specialauthdrugs.html.
  8. Régie de l’assurance maladie Québec. Médicaments couverts – Listes et autres documents. Available at: https://www.ramq.gouv.qc.ca/fr/professionnels/pharmaciens/medicaments/Pages/liste-medicaments.aspx#assure.
  9. Saskatchewan Formulary Bulletin. 2019-04-01. Available at: http://formulary.drugplan.ehealthsask.ca/Bulletins/Bulletin-0175-Apr-2019.pdf.
  10. Saskatchewan Formulary Bulletin. 2018-04-01. Available at: http://formulary.drugplan.ehealthsask.ca/Bulletins/Bulletin-0175-Apr-2019.pdf.
  11. Government of Saskatchewan. Saskatchewan Formulary Bulletin. 2016-05-01. Available at: http://formulary.drugplan.ehealthsask.ca/Bulletins/Bulletin-0158-May-2016.pdf.
  12. Bulletin #100. Available at: https://www.gov.mb.ca/health/mdbif/docs/bulletins/bulletin100.pdf.
  13. Bulletin #87. Available at: https://www.gov.mb.ca/health/mdbif/docs/bulletins/bulletin87.pdf.
  14. Globe & Mail. Drug maker urges patients to speak out as Alberta, Ontario consider switch to cheaper biosimilars. 2019-11-22. Available at: https://www.theglobeandmail.com/canada/article-drug-maker-urges-patients-to-speak-out-as-alberta-ontario-consider/.
  15. Ontario Drug Benefit Formulary. Formulary Search. Available at: https://www.formulary.health.gov.on.ca/formulary.