Biosimilars in Canada: The Generic Version of Biologics
Biosimilars can save Canadians 25% to 50% on expensive biologic drugs. Learn what biosimilars are, how they are approved, and which ones are available in Canada.
What Are Biosimilars?
Biosimilars are the biologic equivalent of generic drugs — but with an important distinction. While a generic drug is a chemical copy of a brand-name medication (identical molecule), a biosimilar is a highly similar version of a biologic drug. Biologic drugs are made from living cells, which means exact replication is not possible. Instead, biosimilars must demonstrate that they are so similar to the original that any differences are clinically meaningless.
Think of it this way: a generic version of atorvastatin is chemically identical to Lipitor. A biosimilar version of Humira (adalimumab) is highly similar to Humira but not molecularly identical — yet it works the same way in your body.
Why Biosimilars Matter
Biologic drugs are among the most expensive medications in Canada. Many cost $15,000 to $50,000 per year. Biosimilars typically cost 25% to 50% less, creating enormous savings for patients, insurers, and provincial drug plans.
Cost Comparison: Biologics vs Biosimilars
| Biologic (Brand) | Biosimilar | Annual Brand Cost | Annual Biosimilar Cost | Savings |
|---|---|---|---|---|
| Humira (adalimumab) | Hadlima, Hyrimoz, Hulio | $20,000 - $24,000 | $12,000 - $16,000 | 30 - 40% |
| Remicade (infliximab) | Inflectra, Renflexis | $25,000 - $35,000 | $15,000 - $22,000 | 35 - 40% |
| Enbrel (etanercept) | Brenzys, Erelzi | $18,000 - $22,000 | $11,000 - $14,000 | 35 - 40% |
| Lantus (insulin glargine) | Basaglar | $2,500 - $3,500 | $1,800 - $2,500 | 25 - 30% |
| Herceptin (trastuzumab) | Ogivri, Herzuma, Trazimera | $45,000 - $55,000 | $28,000 - $35,000 | 35 - 40% |
How Health Canada Approves Biosimilars
Biosimilar approval in Canada is handled through a dedicated pathway that requires extensive evidence:
Required Evidence
The Approval Standard
Health Canada requires that a biosimilar demonstrate no clinically meaningful differences from the reference biologic in terms of:
- Safety (same side effect profile)
- Efficacy (same therapeutic effect)
- Quality (consistent manufacturing)
Provincial Biosimilar Switching Programs
Several Canadian provinces have implemented mandatory switching programs that transition patients from expensive biologics to approved biosimilars:
| Province | Program Status | Key Details |
|---|---|---|
| British Columbia | Active since 2019 | First province to implement; covers 7 drug categories |
| Alberta | Active since 2020 | Mandatory switch for public drug plan beneficiaries |
| Ontario | Active since 2022 | Phased rollout across multiple drug categories |
| Quebec | Active since 2022 | Applies to RAMQ beneficiaries |
| New Brunswick | Active since 2021 | Covers select biologic categories |
Biosimilars Available in Canada
As of 2026, Health Canada has approved biosimilars for several major biologics:
Autoimmune Conditions (Rheumatoid Arthritis, Crohn's, Psoriasis)
- Adalimumab biosimilars: Hadlima, Hyrimoz, Hulio, Idacio, Simlandi, Yuflyma
- Infliximab biosimilars: Inflectra, Renflexis, Avsola
- Etanercept biosimilars: Brenzys, Erelzi
Diabetes
- Insulin glargine biosimilar: Basaglar
Cancer
- Trastuzumab biosimilars: Ogivri, Herzuma, Trazimera
- Bevacizumab biosimilar: Mvasi
- Rituximab biosimilars: Truxima, Riximyo
Common Concerns About Switching
Will the biosimilar work as well?
Clinical evidence from millions of patients worldwide shows that biosimilars are equally effective as the original biologic. The switching programs in BC and Alberta have confirmed this in Canadian patients.
What about side effects?
Biosimilars have the same side effect profile as the reference biologic. There is no evidence of increased adverse events in patients who switch.
Can I switch back?
If you experience issues after switching, your doctor can switch you back to the original biologic. In practice, this is rarely necessary.
How to Learn More About Your Options
If you are currently taking an expensive biologic, talk to your doctor or specialist about whether a biosimilar alternative is available. You can also use TransparentMedz to compare pricing on biosimilars and their reference biologics to understand the potential savings for your specific treatment.
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