Handbook for health care professionals on biosimilar biologic drugs: Access to biosimilars and communicating with patients

On this page

• Health Canada's role in biosimilar availability
• Interchangeability and switching
• Building confidence in biosimilars
• Talking about switching
• Biosimilars and drug benefit programs

Health Canada's role in biosimilar availability

Health Canada authorized the first biosimilar in Canada in 2009. Like many jurisdictions, Canada has sought to increase the uptake and use of biosimilars in medical practice. Switching policies implemented by provincial and territorial governments have contributed to this increase.

The potential cost savings from the increased use of biosimilars are significant. Although cost issues are outside the scope of Health Canada's authority as a regulator, access to affordable medications is a key part of our mandate.

While Health Canada's authorization can make a medication available, access and uptake require the collaboration of many different players. These include the:

• Canadian Agency for Drugs and Technologies in Health (CADTH) and Institut national d'excellence en santé et services sociaux (INESSS)
  • makes recommendations on funding and optimal use of health technologies to decision-makers
  • INESSS has implemented an expedited review process for biosimilars
  • CADTH, however, does not usually review biosimilars
• Patent Medicines Prices Review Board (PMPRB)
  • ensures that the prices of patented medicines sold in Canada are not excessive
  • reports on pharmaceutical trends
• pan-Canadian Pharmaceutical Alliance (pCPA), an alliance of the provincial, territorial and federal governments
  • collaborates on a range of public drug plan initiatives to increase and manage access to effective and affordable drug treatments

The availability of biosimilar versions of important biologic drugs also provides:

• the benefit of less reliance on single, global supply chains
• additional options for patient treatment plans (Figure 3)

Source: Health Canada.

Figure 3 - Text description

With increased use of biosimilars, there is a potential for the health care system to avoid unnecessary spending in the future. Physicians, patients and patient organizations, payers, health charities and other stakeholders will have more options to reallocate resources to other areas of patient care. The result will be improved accessibility and patient outcomes.

Interchangeability and switching

In Canada, "interchangeability" often refers to the ability of a pharmacist to change a prescription for a patient from 1 drug to an equivalent drug, without the need for the original prescriber to intervene. Interchangeability includes the concept of substitution.

Health Canada's authorization of a biosimilar is not a declaration of equivalence to the reference biologic drug, since the biosimilar is highly similar but not identical to its reference biologic drug. The authority to declare 2 products interchangeable rests with each province and territory according to its own rules and regulations.

In the context of biosimilar use, "switching" is not the same as "interchangeability". Health Canada uses "switching" to refer to:

• a change from the routine use of a reference biologic drug to the routine use of a biosimilar (and vice versa) or
• a similar change from one biosimilar to another

Provincial and territorial governments determine the circumstances in which switching is acceptable. Policies on switching in some jurisdictions may result in a decision to switch a patient from a reference biologic drug to a biosimilar. Provincial and territorial governments have published guidelines on switching and interchangeability policies within their jurisdictions. These policies vary by jurisdiction.

Building confidence in biosimilars

Health Canada has published information on biosimilars:

• Fact sheet on biosimilar biologic drugs in Canada

Patients may find specific information on a biosimilar in the patient medication information section of that biosimilar's product monograph.

Also, manufacturers of the reference biologic drug (the originator) and the biosimilar drug offer patient support services. You may wish to discuss available patient support services with your patients.

Some patients may have concerns that the data requirements for biosimilars before and after they are authorized for the Canadian marketplace are less rigid. As a result, they may believe that biosimilars are inferior products.

There is an ongoing need to educate patients about the safety and efficacy of biosimilars. As a health care professional, you play a key role in helping patients understand that regulators only authorize biosimilars when they have reviewed evidence that indicates that there are no clinically meaningful differences between the biosimilar and the reference biologic drug.

Talking about switching

Some health care professional groups and patient organizations have concerns about switching patients from reference biologic drugs to biosimilars. A key concern is that the biosimilar drug could provoke an immune response and thus render the biologic treatment less effective.

For these reasons, before we authorize a biosimilar product, we require that sponsors assess for immunogenicity by looking at comparative studies. The purpose of these studies is to rule out clinically meaningful differences between the biosimilar and the reference biologic drug with respect to the risk and impact of immunogenicity.

Health Canada also requires that sponsors continue to assess adverse events, including immunogenicity, and their clinical significance after their product is on the market. That's why we ask that the risk management plan include detailed information on systematic evaluations of the immunogenicity potential of the biosimilar.

Analyses of switching and interchangeability in the EU have shown that immunogenicity is not notably affected by switching between products.

Perceptions about biosimilars not performing to the same level as the originator biologics have, in some cases, caused a nocebo effect. This is where the patient's beliefs and attitudes about biosimilars can cause negative expectations for treatment. These expectations may adversely affect the outcomes of their treatment.

Through regular communications, the health care professional can reassure the patient that:

• the biosimilar has the same medicinal ingredient as its reference biologic drug
• no clinically meaningful difference in response is expected after switching to the biosimilar
• the same rigorous standards of safety, efficacy and quality are used to authorize both products

Biosimilars and drug benefit programs

There is no guarantee of funding through drug benefit programs when Health Canada authorizes a biosimilar or other biologic drug for sale.

In Canada, federal, provincial and territorial public plans and private plans reimburse patients for drugs. Each jurisdiction and third-party insurance plan decides:

• which drugs it will or will not cover
• whether there are specific coverage criteria
• the amount or percentage of costs it will cover

Patients should refer to specific provincial and territorial guidelines and publications for information about funding.