About Biologic and Biosimilar Medications
- Biologic medications are made from living organisms or their cells.
- Biologic medications differ from most other medications that are made solely from chemicals.
- Biologic medications include hormones, blood products, antibodies, genes, and vaccines.
- Biologics treat many different diseases, including Crohn’s disease, ulcerative colitis, rheumatoid arthritis, diabetes, etc.
- A reference biologic or “originator” biologic medication is the first version of a biologic medication to be made.
- A biosimilar medication is the next version of the biologic produced after the reference biologic’s patent expires.
- Biosimilar medications work in the same way as the reference biologic, but are less expensive.
Comparing Biosimilar and Generic Medications
- A generic medication is a simpler molecule than a biosimilar medication and is an exact copy of the original brand name medication.
- Biologic medications are made from live cells and are more complex than traditional medications.
Comparing Biosimilar and Reference Biologic Medications
- Biosimilar medications are highly similar to their reference biologic. The biosimilar will work in the same way as the reference biologic.
- The expected therapeutic effect is the same for both a reference biologic and its biosimilar versions.
- Biosimilar manufacturers submit studies to Health Canada to prove that their biosimilar works as well and is as safe as the reference biologic.
- Each batch of a biologic medication can have minor variations from the first biologic that was made. These minor changes can happen with each batch of a reference biologic and with the biosimilar copies, but do not change the effect or safety of the medication.
Biosimilar Medication Safety
- Health Canada monitors and regulates all medications, including biosimilars.
- All biosimilars approved by Health Canada meet rigorous quality standards to confirm that they are as effective and safe as the reference biologic.
- Biosimilars are produced to the same quality as reference biologic medications.
- In Canada and internationally, there have not been any unexpected safety issues identified for biosimilars.
More Information
- Patients may contact their doctor, nurse or pharmacist with questions about their treatment or about biosimilar medications.
- medSask is a drug information service that provides accurate, evidence-based information on medications and medication therapy to the general public, health care providers and other collaborators. medSask is available to support patients and health care providers with questions about biosimilar drugs.
- Support for patients:
- Visit medSask – Biosimilars in Saskatchewan - General Public
- Email med.sask@usask.ca
- Call 1-800-665-3784 (306-966-6378 in Saskatoon)
- Support for health care providers:
- Visit medSask – Biosimilars in Saskatchewan
- Email druginfo@usask.ca
- Call 1-800-667-3425 (306-966-6340 in Saskatoon)
- Patients and prescribers can refer to the Resources and Studies section of the Saskatchewan Biosimilars Initiative website for trustworthy information on biosimilar medications.
- For general questions about the Saskatchewan Biosimilars Initiative, patients can contact the Drug Plan at sk.biosimilars@health.gov.sk.ca or call 1-800-667-2549 (306-787-8744 in Regina), and press 2, then 2.