1. What is a biologic? What is a biosimilar?
Biologic drugs (originators and biosimilars) are made using living organisms (e.g., yeast or animal cells) rather than being synthetically manufactured. This class of drugs is designed to treat various conditions by affecting certain processes within the body.
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. What are the benefits of biosimilars?
Although biologics help treat patients with serious diseases, they are complex drugs and can be very expensive and time consuming to develop. Therefore, access to these medications is limited and it is difficult for the healthcare system to afford originator versions.
Since biosimilars are developed based on a foundation of biologic work, they are less expensive to produce, do not compromise efficacy and safety, and lead to major cost savings that can be reinvested into our healthcare system. A healthy and competitive drug market can support diverse manufacturers to produce new and affordable drugs.
3. What are the experts saying? 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 have found no meaningful differences in safety and effectiveness compared to the originator version. The biosimilars involved in the Biosimilars Initiative have all been approved by Health Canada.
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 in the table above. You will need to switch to the biosimilar version before the end of the switch period in order to avoid any disruption to your coverage.
5. Will a biosimilar work for me?
Though a biosimilar biologic is not identical to an originator biologic, there are no clinically meaningful differences between them. 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 based on your medical background and what the differences are between the available medications.
6. What is the nocebo effect and how can I prevent it?
The nocebo effect occurs when a patient’s negative expectations affect the treatment outcomes. A patient’s mindset can impact their symptoms and their sense of wellbeing. 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 address a possible nocebo effect, you can:
- Acknowledge the nocebo effect
- 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
7. What if I can’t switch to a biosimilar?
There may be exceptions where some patients cannot switch to a biosimilar biologic for exceptional medical reasons. Your prescriber can help you determine why 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.
8. I take Remicade® or Rituxan®, which are biologics that are administered through an infusion. If I switch to the biosimilar, do I have to go to a different infusion centre?
As part of the biosimilar switch, you may switch to a new infusion centre to receive your infusion of the biosimilar version. The patient support program offered by the manufacturer of the biosimilar version will coordinate this change.
9. 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 supplied by the manufacturers of the biosimilars. Information on patient support programs and infusion clinics is available online.
10. 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.
11. Can switching be done during COVID-19?
Yes, as the Department of Health has introduced temporary virtual care options, so patients may not need to physically go to a doctor’s office.