Biologic and Biosimilar Drugs: FAQs
What is a biologic drug?
- Biologic drugs are made from living organisms or their cells.
- They differ from most other drugs that are made from chemicals.
- Biologic drugs include hormones, blood products, antibodies, genes and vaccines.
- Biologics treat many different diseases, including Crohn’s and colitis, rheumatoid arthritis and diabetes.
What is a reference or originator biologic?
- The first version of a biologic drug to be produced is called the reference or originator.
What is a biosimilar drug?
- Biosimilar drugs are the next versions of the biologic drug produced after patent expiry of the reference biologic drug.
- Biosimilars work in the same way as the reference biologic drug, but are less expensive.
- Patients can expect the same results from biosimilars as the reference biologic they are familiar with.
Is a biosimilar drug the same as a generic?
- No. A generic drug is a simpler molecule and is an exact copy of the original brand name medication.
- Biologic drugs are made from live cells and are more complex than traditional drugs.
- Biosimilar drugs are highly similar to their reference biologic. The biosimilar will work in the same way as the reference biologic.
- Each batch of a biologic drug 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 drug.
Is a biosimilar drug as effective as a reference biologic?
- Biosimilars work in the same way as the reference biologic.
- Patients can expect the same efficacy from biosimilars as the reference biologic.
- Biosimilar manufacturers submit studies to Health Canada to prove that their biosimilar works as well and is as safe as the reference biologic.
Are biosimilar drugs safe?
- Health Canada monitors and regulates all drugs, including biosimilars.
- Health Canada ensures biosimilar drugs are as effective and safe as their reference biologic version.
- Biosimilars are produced with the same regulatory standards as reference or originator biologic drugs.
- In Canada and internationally, there have not been any unexpected safety issues identified for biosimilars.
Biosimilars Initiative: FAQs for Patients
What is the Biosimilars Initiative?
- The Biosimilars Initiative requires patients to use a biosimilar version of their medication where one is available, in order to maintain their Saskatchewan Drug Plan coverage.
- This coverage policy will apply to future reference biologics as biosimilar drugs are launched and listed on the Saskatchewan Formulary.
Does the Biosimilars Initiative apply to all patients?
- The Biosimilars Initiative applies to patients receiving Saskatchewan Drug Plan coverage of a reference biologic drug on the list of drugs affected.
- Exemptions for a patient to maintain coverage of a reference biologic will be considered for those who cannot use a biosimilar for a medical reason. Prescribers can submit a request and supply clinical rationale for review on a case-by-case basis.
- Please note: patients will continue to be able to access Saskatchewan Drug Plan coverage of their reference biologic medication if a suitable biosimilar format is not available.
Why is this policy needed?
- Biosimilar drugs are becoming available in Canada now that older reference biologic drugs are losing their patent protections.
- Biosimilars are produced with the same quality as reference biologics, but can be made at a much lower cost. Biosimilars cost less because they are based on work already done to develop the reference biologic drug.
- Biosimilar drugs present a significant opportunity for cost savings.
- Using biosimilars supports health system sustainability while having safe and effective medication options.
- The Biosimilars Initiative will support patient access to public drug coverage and new drug benefits now and into the future.
- Several public drug plans across Canada have put in place similar policies to increase uptake of biosimilar drugs.
How do I find out if I need to switch to a biosimilar?
- Patients will be contacted directly by letter if they may need to start using a biosimilar version of their medication to keep their Saskatchewan Drug Plan coverage.
- Patients already receiving treatment with a reference biologic drug on the list of drugs affected will need to start using a biosimilar version before the end of the transition period in order to maintain their Saskatchewan Drug Plan coverage.
- After the announced transition period, the Saskatchewan Drug Plan will no longer cover the reference biologic drug.
- Patients should contact their doctor, nurse, or pharmacist with questions about their treatment or about biosimilar medications.
How do I keep my coverage if I need to switch?
- Patients should check the list of drugs affected to see if they need to use a biosimilar to be eligible for Saskatchewan Drug Plan coverage of this medication.
- Before the end of a transition period, patients are encouraged to contact the health care provider who prescribes their biologic medication.
- Patients should talk to their health care provider, including their pharmacist, about the available biosimilar options and get a new prescription for the biosimilar. A new prescription is required to start receiving the biosimilar at a pharmacy or clinic.
- If you are using a reference biologic insulin, you can also ask your pharmacist to help you transition to a biosimilar insulin.
- Patients may have the option to enrol in a new biosimilar patient support program (health care providers can help with this).
- After the announced transition period, the Saskatchewan Drug Plan will no longer cover the reference biologic drug.
If I keep using the reference biologic even though a biosimilar version is available, will the Saskatchewan Drug Plan cover up to the cost of the biosimilar?
- No. After the end of a transition period, the Saskatchewan Drug Plan will no longer cover the reference biologic drug.
- Patients will be responsible for the cost of their reference biologic treatment unless they have an approved exemption.
What if I have private coverage?
- The Biosimilars Initiative applies to patients receiving Saskatchewan Drug Plan coverage of a reference biologic drug in the list of drugs affected.
- Your private insurance provider may co-ordinate your benefits with the Saskatchewan Drug Plan.
- Contact your private insurance provider with questions about your private drug coverage benefits and how the Saskatchewan Biosimilars Initiative may apply to your private benefits.
Will my medication costs change when I start using a biosimilar?
- The cost of medication will vary based on an individual’s coverage, deductible and/or copayment.
- For questions related to drug coverage, contact the Drug Plan at 1-800-667-7581 or 306-787-3317 (Regina) or DPEB@health.gov.sk.ca.
When do I need to start using a biosimilar?
- If you already have Saskatchewan Drug Plan coverage for one of the listed reference biologics, you will need to start using a biosimilar version before the end of the announced transition period.
- Until the end of the announced transition period, you will be eligible for coverage of both the reference biologic drug and any listed biosimilar(s).
- After the end of a transition period, the Saskatchewan Drug Plan will no longer cover the reference biologic drug unless you have an approved exemption.
What if I can’t use a biosimilar?
- Exemptions for a patient to maintain coverage of a reference biologic will be considered for those who cannot use a biosimilar for a medical reason. Prescribers can submit a request and supply clinical rationale for review on a case-by-case basis.
- Please note: patients will continue to be able to access Saskatchewan Drug Plan coverage of their reference biologic medication if a suitable biosimilar format is not available.
What if I don’t think a biosimilar will work?
- It is natural to be curious about changes to your treatment.
- Biosimilars work in the same way as the reference biologic; there are no clinically meaningful differences between the two drugs.
- Biosimilar manufacturers submit studies to Health Canada and go through a rigorous process to prove that their biosimilar works as well and is as safe as the reference biologic.
- You can, therefore, expect the same efficacy from biosimilars as the reference biologic.
- Science tells us that sometimes, our mindsets can influence our symptoms and sense of well-being. When negative expectations influence treatment outcomes, this is called the nocebo effect. Misinformation from a variety of sources can contribute to the nocebo effect.
- To prevent a nocebo effect, you can:
- Recognize the possibility of the nocebo effect
- Find trustworthy information on biosimilars (see the Resources and Studies section)
- Speak to your doctor, nurse, or pharmacist about your biosimilar questions and options
- Keep a neutral or positive outlook and acknowledge the rigorous process that goes into development of these drugs
- Be confident that a growing number of patients around the world are safely using biosimilar treatments
- Trust that your health care team is available if you have any questions or concerns about your treatment
What supports are available?
- Patients may contact their doctor, nurse, or pharmacist with questions about their treatment or about biosimilar medications.
- Many biosimilar manufacturers have Patient Support Programs and services to assist patients starting and transitioning to a biosimilar drug. See Patient Support Programs for more information.
- medSask is a drug information service available to support patients and health care providers with questions about their biologic drug treatment.
- Patients can refer to the Resources and Studies section for trustworthy information on biosimilars.
- For general questions about the Saskatchewan Biosimilars Initiative, patients can contact the Drug Plan at sk.biosimilars@health.gov.sk.ca or call 1-800-667-7581 (306-787-3317 in Regina).
Who was consulted as part of the implementation of the Biosimilars Initiative?
- The Saskatchewan Drug Plan consulted with health care providers, prescribers, drug manufacturers and patient groups. The Drug Plan continues to also work closely with other public drug plans that have put in place similar policies.
- The Saskatchewan Drug Plan is committed to continue working with patients, prescribers, and other stakeholders to address any concerns related to the Biosimilars Initiative.
Are cancer drugs included and will cancer patients need to switch?
- The Biosimilars Initiative will currently impact biologics and biosimilars listed on the Saskatchewan Drug Plan Formulary and does not include those covered through the Saskatchewan Cancer Agency.
- The Saskatchewan Cancer Agency is already using several biosimilar drugs to treat various cancers.
Biosimilars Initiative: FAQs for Prescribers
What is the Biosimilars Initiative?
- The Biosimilars Initiative requires patients to use a biosimilar version of their medication where one is available, in order to maintain their Saskatchewan Drug Plan coverage.
- Existing patients already receiving treatment with a reference biologic drug on the list of drugs affected will need to start using a biosimilar by the end of the listed transition period.
- This coverage policy will apply to future reference biologics as biosimilar drugs are launched and listed on the Saskatchewan Formulary. Health care professionals and patients will be given notice of these changes in the future.
Which medications are affected by the Biosimilars Initiative?
Please refer to the list of drugs affected for the reference biologic drugs currently affected by the Saskatchewan Biosimilars Initiative.
Does the Biosimilars Initiative apply to all patients?
- The Biosimilars Initiative applies to patients receiving Saskatchewan Drug Plan coverage of a reference biologic drug on the list of drugs affected.
- Exemptions for a patient to maintain coverage of a reference biologic will be considered for those who cannot use a biosimilar for a medical reason. Prescribers can submit a request and supply clinical rationale for review on a case-by-case basis.
- The Exemption Request Form can be found in the Prescriber Forms section.
- Please note: patients will continue to be able to access Saskatchewan Drug Plan coverage of their reference biologic medication if a suitable biosimilar format is not available.
Why is a biosimilar switching policy necessary?
- Biosimilars present a significant opportunity for cost savings and health system sustainability. Biosimilars are up to 40% less expensive than reference biologics at list price and they are safe and effective.
- Transitioning patients to less-expensive biosimilars is expected to result in significant health system savings.
- The Biosimilars Initiative will support patient access to public drug coverage and new drug benefits, now and into the future.
What can I do to transition patients to a biosimilar?
- Review the list of drugs affected and the transition period date(s).
- Identify patients who may need to use a biosimilar version of their medication in order to keep their Saskatchewan Drug Plan coverage. Prescribers can request a list of patients who are using a biologic included in the Initiative by completing the Patient List Request Form and emailing it to sk.biosimilars@health.gov.sk.ca. See the Prescriber Forms section.
- Work with your patient to discuss their questions or concerns about their treatment, including biosimilar drugs.
- Update the patient’s biologic prescription with the chosen biosimilar. If applicable, support the patient’s enrolment in the biosimilar patient support program.
- Patients using a reference biologic insulin can also ask their pharmacist to help them transition to a biosimilar insulin, without a prescription from a primary care or specialist prescriber.
- Where applicable, patients will have Exception Drug Status (EDS) coverage proactively added for the biosimilars. You will not need to submit an EDS application for your patient to start using a biosimilar.
When do patients need to start using a biosimilar? Is there a transition period?
- There will be a transition period where both the reference biologic drug and biosimilar(s) will be covered.
- Patients already receiving treatment with a reference biologic drug on the list of drugs affected will need to start using a biosimilar version by the end of the transition period as noted in the List of drugs affected in order to maintain their Saskatchewan Drug Plan coverage.
- After the transition period, the Saskatchewan Drug Plan will no longer cover the reference biologic drug.
What if a patient can’t switch to a biosimilar?
- Exemptions for a patient to maintain coverage of a reference biologic will be considered for those who cannot use a biosimilar for a medical reason. Prescribers can submit a request and supply clinical rationale for review on a case-by-case basis.
- The Exemption Request Form can be found in the Prescriber Forms section.
- Please note: patients will continue to be able to access Saskatchewan Drug Plan coverage of their reference biologic medication if a suitable biosimilar format is not available.
What supports are available to patients?
- Patients may contact their doctor, nurse, or pharmacist with questions about their treatment or about biosimilar medications.
- Patients and prescribers can refer to the Resources and Studies section for trustworthy information on biosimilars.
- Many biosimilar manufacturers have Patient Support Programs and services to assist patients starting and transitioning to a biosimilar drug. See Patient Support Programs for more information.
- medSask is a drug information service available to support patients and health care providers with questions about their biologic drug treatment.
- For general questions about the Saskatchewan Biosimilars Initiative, patients can contact the Drug Plan at sk.biosimilars@health.gov.sk.ca or call 1-800-667-7581 (306-787-3317 in Regina).
What supports are available to prescribers?
Who was consulted as part of the implementation of the Biosimilars Initiative?
- The Saskatchewan Drug Plan consulted with health care providers, prescribers, drug manufacturers and patient groups. The Drug Plan also continues to work closely with other public drug plans that have put in place similar policies.
- The Saskatchewan Drug Plan is committed to continue working with patients, prescribers and other stakeholders to address any concerns related to the Biosimilars Initiative.
