1. What are biologic and biosimilar drugs?
Biologics (originators and biosimilars) are complex drugs that are made from living cells rather than being synthetically manufactured.
When patents for originator biologics expire, other manufacturers may produce biosimilar versions. Biosimilar biologics are not identical to originator biologics due to their complex structure. However, biosimilars are highly similar to the originator and are tested to ensure the same health outcomes and level of safety.
2. Are biosimilars safe?
Health Canada is responsible for ensuring the safety, efficacy, and quality of all new drugs including biologics (originators and biosimilars). Before a biosimilar drug can be approved in Canada, Health Canada must determine there are no meaningful differences in safety and effectiveness compared to the originator. The biosimilars involved in the Biosimilars Initiative have all been approved by Health Canada.
3. What are the benefits of biosimilars?
Since originator biologics can be very expensive, access to these medications is limited and they are difficult for the healthcare system to afford. Biosimilars are less expensive to produce and lead to significant cost savings that can be reinvested into our public drug plans without compromising efficacy and safety.
By switching to a biosimilar, you are helping to save millions of dollars every year. This will make the New Brunswick Drug Plans more sustainable, expand coverage for new treatments and improve patient access to more medications.
4. Do I have to switch to a biosimilar?
Yes, if you are covered by the New Brunswick public drug plans and using any of the originator biologics included in the Biosimilar Initiative. To avoid any disruption in your coverage, you will need to switch to the biosimilar version before the Coverage End Date specified in the table above.
5. What is the process for switching?
If you are using a biologic that is included in the Biosimilars Initiative:
- Make an appointment with your prescriber that will occur before the Coverage End Date specified in the table above
- Discuss the switch with your prescriber
- Your prescriber can explain the switching process, discuss your biosimilar options, and write you a new prescription
- Ensure you switch before the end of the switch period Coverage End Date specified table above to maintain your continued coverage by the New Brunswick Drug Plans.
6. Will a biosimilar work for me?
There are no clinically meaningful differences between originators and biosimilars. A biosimilar drug delivers similar effectiveness, level of safety, and the same therapeutic benefits to patients. Health Canada assures patients and health professionals that biosimilars are safe and effective. Moreover, Health Canada expects no differences following a change in routine use between an originator and its biosimilar for diseases they are approved to treat.
Ask your prescriber about your options and what the differences are between the available medications.
7. What if I don’t think a biosimilar will work as well as the originator?
A patient’s mindset can impact their symptoms and their sense of wellbeing. When a patient’s negative expectations affect the treatment outcomes, this is called the nocebo effect. Factors that can contribute to experiencing the nocebo effect are mental health issues, language barriers, relying on unbalanced online media as an information source, negative interactions with healthcare professionals and settings, etc.
To prevent a nocebo effect, you can:
- Seek out more information on biosimilars (see the Resources section below)
- Speak to your prescribing doctor or pharmacist about the switch and discuss your options
- Stay informed about the switch process
- Keep a neutral or positive outlook
8. What if I can’t switch to a biosimilar?
There may be some patients who cannot switch to a biosimilar for exceptional medical reasons. Your prescriber can help you determine if it is medically necessary to remain on an originator biologic. A special authorization request may then be submitted by the prescriber to consider approval for continued coverage of an originator biologic.
9. I take a biologic that is administered through an infusion. If I switch to the biosimilar, do I have to go to a different infusion centre?
You may need to go to a new infusion centre to receive your infusion of the biosimilar version. If required, the patient support program offered by the manufacturer of the biosimilar version will coordinate this change.
10. What are patient support programs?
Patient support programs are available to help patients switching to most of the biosimilars in the Biosimilars Initiative. These programs are provided by the manufacturers of the biosimilars. Information on patient support programs and infusion clinics is available online.
11. What if I have private coverage?
If you do not rely on the New Brunswick Drug Plans for coverage of your originator biologic, the Biosimilars Initiative will not directly affect you. However, as some private insurers offering employer-sponsored plans have also been implementing biosimilar switch policies, you may wish to contact your private insurer for more information.
If your originator biologic is covered by the New Brunswick Drug Plans because it is not covered by your private plan or you have reached an annual or lifetime maximum for drug coverage, you will need to switch to a biosimilar brand to maintain coverage. The letter from your private plan that is required with your annual application must confirm that the originator biologic and biosimilar brands are not listed on your private plan’s formulary.
12. Do I have to see my physician in their office to discuss switching to a biosimilar?
An appointment with your physician may be in-person or virtual (phone or video call). Ask your physician’s office which option would work best.