The advancement of biologics and biosimilars have realized tremendous treatment breakthroughs for people living with a wide range of diseases. Everything ranging from diabetes, to types of cancers, to forms of inflammatory arthritis like Rheumatoid Arthritis and Ankylosing Spondylitis, to Psoriasis, to Inflammatory Bowel Diseases (primarily Crohn’s Disease and ulcerative colitis) have demonstrated improved health outcomes thanks to these types of medications.
Some biologics have been available in Canada for close to 20 years. But patients have many questions about both biologics and biosimilars, how they work and how they are funded. The Health Coalition of Alberta has created this Resource Centre to provide answers. If you have any outstanding questions or would like to share your experience with accessing biologics and biosimilars, please contact us.
What is a Biologic?
Biologics are complex, large molecule medications developed in living cells. They are made using human or animal tissue or micro-organisms as a starting material and are produced using unique, intricate processes. As a result, each medication has a distinctive composition. They are not manufactured chemically, like most small-molecule medications that are commonly available to patients. In some cases, biologics work by targeting key cells and shutting down the ability to trigger inflammation. Examples of biologic drugs include insulin, growth hormones and antibodies. They can be administered via intravenous infusion at a clinic by healthcare professionals or by injection.
What is a Biosimilar?
Due to the complexity of the medication, biologics are not able to be replicated as identical generics. However, they can be copied in the form of a biosimilar. Biosimilars are deemed to be highly similar to their originator or reference biologic. Biosimilar manufacturers abide by the same regulatory standards as originator biologics and must undergo a rigorous scientific evaluation by Health Canada. A biosimilar may enter the market after the originator biologic patents and data protection expires. The introduction of biosimilars into the Canadian marketplace provides healthcare providers and patients additional treatment choices. They also may offer a lower cost option to insurance plan providers and patients.
Are these medications safe?
Health Canada reviews the biosimilar manufacturer’s product submission, including its effectiveness and safety profile, prior to it being authorized for sale in Canada. According to Health Canada, patients can have confidence that “no differences are expected in efficacy and safety following a change in routine use between a biosimilar and its reference biologic drug in an authorized indication”. Although biosimilars have only been introduced to Canadians in the past few years, it should be noted that they have been used by patients in Australia, the United States, Great Britain and the European Union for more than 10 years. Some countries have incorporated biosimilars through a required switch program while others have achieved cost effective uptake voluntarily while maintaining patient and healthcare provider choice.
Moving on to a Biosimilar
Public access to both originator and biosimilar biologics in Alberta are guided by the Biosimilars Initiative. In December 2019, the Alberta Government announced the expansion of the Biosimilars Initiative for patients who are part of a publicly funded drug program (Alberta Seniors Benefit, AISH, Non-Group Coverage, etc.) For more information on Alberta’s public drug plans you can visit the Alberta Health website here.
You can learn more about the Biosimilars Initiative here, but remember that this program impacts only public drug plans in Alberta. Also, patients under the age of 18 or who are pregnant are exempt and will continue to use their current biologic.
Newly prescribed patients will have access to a list of biosimilars outlined by disease-state in Tier One of the program. The tiering program means patients have to fail on a required number of products in tier one before they can move to a tier two product – typically an originator biologic without a biosimilar at this time.
Patients currently using an originator biologic will be moved onto a corresponding biosimilar by January 15, 2021. It is important to discuss this move with your healthcare provider. If there are medical concerns regarding the appropriateness of a change in product, your healthcare provider can request exceptional coverage of the originator biologic. The Alberta Government has created an exemptions review committee made up of healthcare professionals with experience in both originator and biosimilar biologics. The parameters for granting an exemption have not been defined and will be established as the committee reviews individual cases. Therefore, it is important to discuss your concerns about a switch to a biosimilar with your healthcare provider if you think you have a reason to be exempt from this program.
This program does not impact patients who have private insurance coverage. You are encouraged to speak to your insurance provider to find out details about your private plan.
Questions for Patients
The Health Coalition of Alberta supports patients and healthcare providers working in partnership to make educated treatment choices that are based on achieving improved health outcomes. We recommend you talk to your healthcare provider to ensure you completely understand your treatment benefits, any adverse effects, and how your medication use will be monitored in order to feel confident about your treatment pathway. Some key questions to ask include:
- What can I expect from this treatment?
- What are the side effects?
- Is there any way to monitor the safety of biosimilars? If so, who does that?
- Are there any special considerations if I have other health issues? Become pregnant?
- Does this treatment affect other medications I am taking?
- What do I need to do to keep my biologic/biosimilar safe at home or while I travel?
- Is it safe to switch to a biosimilar even though my biologic is working for me?
- With your medical background, are there any reasons why I should not change to the biosimilar?
- Will the medication delivery device work the same way? Will I need additional training?
- Is this biosimilar as readily available as my current biologic?
- Will I get the same or additional support to manage the biosimilar as I received with the original biologic?
- Will I be able to switch back to my previous medication if the biosimilar does not work as effectively?
- What happens if this biosimilar doesn’t work for me?
- What is the chance that I could be given a different biosimilar at another time?
Alberta’s Biosimilar Initiative
Alberta’s Biosimilar Initiative – HCA Infographic
Alberta Blue Cross administers the publicly funded drug plans in Alberta. You can find patient information here.
Health Canada fact sheet
CADTH fact sheet
Many of our members provide disease-specific information about originator and biosimilar biologics: