On August 1, 2024, Manitoba became the last Canadian province to implement a biosimilar transition policy for its public drug plan. With this move, all ten provinces now require patients using certain originator biologic medications to switch to biosimilar alternatives.
The transition has been years in the making. British Columbia led the way in 2019, and provinces have followed at their own pace since then. Manitoba's policy and Ontario's parallel transition, both with deadlines extending to January 31, 2025, mark the completion of a national shift toward biosimilar use on public formularies.
What Are Biosimilars?
Biosimilars are biologic medications that are highly similar to an already approved reference biologic (the originator). They are not identical copies like generic versions of chemical drugs, because biologic medications are produced using living cells and have complex molecular structures. However, Health Canada requires biosimilars to demonstrate that there are no clinically meaningful differences from the originator in terms of safety, efficacy, and quality.
Biosimilars go through a rigorous regulatory review before approval. Health Canada evaluates extensive analytical, non-clinical, and clinical data to confirm that a biosimilar performs the same way as its reference product in patients.
Which Medications Are Affected?
The transition policies target some of the most widely used and expensive biologic medications. Patients on public drug plans using originator biologics for conditions such as rheumatoid arthritis, inflammatory bowel disease (Crohn's disease and ulcerative colitis), psoriasis, and diabetes are affected.
Common originator-to-biosimilar switches include products in the infliximab, adalimumab, etanercept, and insulin glargine categories. The specific biosimilar alternatives vary by province, but the principle is the same: if a biosimilar is available and listed on the provincial formulary, patients on public plans are expected to switch.
Manitoba and Ontario Timelines
Manitoba's policy, effective August 1, 2024, gave patients on Manitoba Pharmacare until January 31, 2025, to complete the switch. During the transition period, the originator biologic remained covered to allow time for patients and their healthcare providers to plan the change.
Ontario ran a parallel transition with a similar timeline. Patients on the Ontario Drug Benefit program using affected originator biologics had from July 31, 2024, to January 31, 2025, to transition to a biosimilar.
Both provinces provided exemption processes for patients who could not switch due to documented medical reasons. These exemptions require supporting clinical evidence from the prescribing physician.
Why the Push to Biosimilars?
The primary driver is cost. Originator biologics are among the most expensive medications on provincial formularies. A single patient's annual biologic therapy can cost $15,000 to $30,000 or more. Biosimilars typically cost 25% to 50% less than their originator counterparts.
Across all ten provinces, the savings from biosimilar switching are projected to reach billions of dollars over the coming years. These savings can be redirected to fund coverage for new and innovative therapies, expand access to existing medications, or address other healthcare priorities.
British Columbia, which implemented its policy earliest, has already reported significant savings that have been reinvested into its public drug plan.
The Pharmacist's Role
Pharmacists are central to the biosimilar transition. They are often the first point of contact for patients who have questions or concerns about switching.
Patient counseling. Many patients are anxious about changing a medication that has been working for them. Pharmacists can explain that biosimilars have been rigorously tested and approved by Health Canada, and that switching is supported by clinical evidence.
Coordination with prescribers. Pharmacists may need to follow up with prescribers to obtain new prescriptions for the biosimilar product. In some provinces, pharmacists can facilitate the switch through therapeutic substitution authority.
Monitoring after the switch. Patients who switch to a biosimilar should be monitored for any changes in their condition. Pharmacists can schedule follow-up consultations to check on patients' progress and address any concerns.
Documentation. Proper documentation of the switch, including the date of transition, the specific products involved, and any patient-reported outcomes, is important for continuity of care.
Looking Forward
The completion of biosimilar transition policies across all provinces is a milestone for Canadian pharmaceutical policy. It demonstrates that coordinated, evidence-based drug policy can reduce costs while maintaining patient safety. As new biosimilars enter the market for additional biologic categories, further transitions are likely. Pharmacies that have built strong patient communication and transition management processes will be well prepared for whatever comes next.