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Efficacy of biosimilars vs. reference biologics
Safety of biosimilars vs. reference biologics
Manufacturing process for biosimilars
Switching patients from a reference biologic to a biosimilar
Patient support programs for biosimilars
Approval processes for biosimilars
Biosimilar supply chain

Getting to know biosimilars

Biosimilars vs. their reference biologics

Biosimilars are biologic medicines that are highly similar to their reference biologic drug. Biosimilars have no clinically meaningful differences from their approved reference product in terms of: 1                                                       

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Safety
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Purity
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Potency

Biosimilars are approved by Health Canada based on a thorough comparison to a reference drug and may only enter the market after the expiry of the reference biologic drug's patents and data protection. 1

Man on a microscope

Biosimilars are NOT generics1

 

Generic drugs are chemical-based, small-molecule drugs that contain medicinal ingredients identical to their reference products.

Biologics and biosimilars are large, complex molecules developed inside living cells and so are naturally variable.

Manufacturing process of biosimilars

Biosimilars are manufactured to the same regulatory standards as other biologic drugs. They are highly similar, but not identical, and are manufactured by independent processes. 1

Biosimilars display an inherent degree of minor variability, which is tightly controlled.2

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Made in living organisms and purified via a complex manufacturing process
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Consist of relatively large and highly complex molecular entities
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Display minor variability, even between different batches of the same product; this normal feature is tightly controlled
Man looking at a test tube

Teva Canada is committed to ensuring that any biosimilar we deliver and manufacture is produced in state-of-the-art facilities and made with the highest-quality agents.

The range in variability allowed in biosimilars is the same as in the reference medicine.

We are committed to building on a well-established and trusted history in manufacturing and supplying medications through the investment in and development of biosimilars in Canada.

Switching patients from a reference biologic to a biosimilar

Switching generally refers to a change from routine use of a reference biologic to routine use of a biosimilar. 1, 3

According to Health Canada, patients and healthcare providers (HCPs) can be confident that biosimilars are effective and safe for each of their authorized indications. 1, 3

A huge majority of single-switch studies didn’t report differences in efficacy, safety, and immunogenicity compared to patients not switched.4

 

Health Canada recommends that a decision to switch should be made by the treating physician in consultation with the patient and taking into account: 3

  • Available clinical evidence
  • Any policies of the relevant jurisdiction
Older woman on a beach

Biosimilar switching policy

Recent policy changes to promote biosimilar switching are expected to result in significant cost reductions for relevant classes of biologics in Canada. These endeavours should help to offset the pressure from new higher-cost medicines in coming years. 5

Biosimilars in the Canadian market

The use of biosimilars continues to grow in Canada: 6 

- More than 50 biosimilars are authorized for sale in Canada.
- > 1.77 million retail prescriptions for biosimilar medicines are filled annually.
- Patent expiries present opportunities for more biosimilars.

Biosimilars contribute to the sustainability of the healthcare system via: 3

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Reduced cost
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Increased competition
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Improved drug accessibility

At Teva, we recognize that biosimilars offer significant opportunities and benefits for Canadians. That’s why we still focus our research and development efforts on biosimilars that consumers and providers can trust.

       

Patient support programs for biosimilars

Woman therapist

Teva Support Solutions® is a comprehensive program that provides support services to patients and prescribers of Teva’s biosimilars.

Biosimilar manufacturers are committed to minimizing the impact of switching for both patients and prescribers. They have implemented patient support programs (PSPs) that offer similar processes and services as the originator biologic to ensure a seamless transition.

PSPs can offer a range of services, including but not limited to:

  • Nursing support
  • Reimbursement navigation
  • Ongoing pharmacovigilance

Approval processes for biosimilars


Health Canada has developed a robust, science-based regulatory framework for biosimilars.

The rigorous standards for authorization mean that patients and HCPs can have the same confidence in a biosimilar vs. its reference biologic with respect to: 1, 5

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Safety
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Purity
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Potency

How is similarity between a biosimilar and a reference biologic drug demonstrated to Health Canada?


Similarity is demonstrated using comparative studies via a step-wise approach:

1. Structural and functional studies
2. Human clinical studies                            

Given that the aim of these studies is to demonstrate similarity, the type of data required to support biosimilar authorization differs from that required for a stand-alone biologic drug. 1

 

 

Reference biologic vs. biosimilar regulatory pathway1

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                  PK: Pharmacokinetics; PD: Pharmacodynamics
       

 

Man holding a tablet

 

Manufacturers must independently demonstrate similarity in structure, function, efficacy, and safety to the previously authorized reference biologic drug. 1

References:

  1. Back to contents.

    Government of Canada. Biosimilar biologic drugs in Canada: fact sheet. Available from: https://www.canada.ca/content/dam/hc-sc/migration/hc-sc/dhp-mps/alt_formats/pdf/brgtherap/applic-demande/guides/Fact-Sheet-EN-2019-08-23.pdf. Accessed May 26, 2023.

  2. Back to contents.

    Biosimilars Canada. Chapter 4. Biosimilar medicines – a commitment to scientific excellence. Available from: https://biosimilarscanada.ca/resources/biosimilars-101/. Accessed June 5, 2023.

  3. Back to contents.

    Edwards S et al. Primer on biosimilars. Available from: https://careeducation.ca/wp-content/uploads/2019/06/biosimilarsprimer_final.pdf.                          Accessed May 26, 2023.

  4. Back to contents.

    Biosimilars Canada. Chapter 6. Building on the experience and success of biosimilar medicines. Available from: https://biosimilarscanada.ca/resources/biosimilars-101/. Accessed June 5, 2023.

  5. Back to contents.

    Government of Canada. Canada’s evolving market for biosimilars and what it means for payers. Available from: https://www.canada.ca/content/dam/pmprb cepmb/documents/npduis/analytical-studies/posters/2022/BiosimilarsInCanada_Poster_EN_ISPOR2022.pdf. Accessed May 26, 2023.

  6. Back to contents.

    Biosimilars Canada. Switching. Available from: https://biosimilarscanada.ca/resources/switching/. Accessed June 5, 2023.