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Health Canada publishes biosimilars fact sheet Posted 06/12/2019

Health Canada has published a fact sheet on biosimilars, which aims to provide a comprehensive overview on a number of issues concerning biosimilars.

The guide, titled ‘Biosimilar Biologic Drugs in Canada: Fact Sheet’ starts by reiterating that ‘Health Canada authorizes biosimilars for sale using the same rigorous regulatory standards for quality, efficacy and safety as for all other biologic drugs’. It also defines a biosimilar as ‘a biologic drug that is highly similar to a biologic drug that was already authorized for sale’.

The fact sheet includes section on subjects including:
• Biosimilars versus generics
• How biosimilars are regulated in Canada
• Information requirements for authorization of a biosimilar
• Roles of structural, functional, non-clinical and clinical studies
• Why some biosimilars are authorized for fewer indications than the reference biological
• Immunogenicity issues for biosimilars
• Monitor the safety of biosimilars after authorization
• Comparing Canada's biosimilar regulatory framework with those of other countries
• Naming convention for biologicals including biosimilars
• Availability of biosimilars in Canada
• Interchangeability
• Switching

Health Canada regulates biosimilars as new drugs under the Food and Drugs Act and the Food and Drug Regulations [1]. Biosimilar manufacturers must demonstrate similarity using comparative studies via a stepwise approach, beginning with structural and functional studies and continuing with human clinical studies. Health Canada evaluates whether the information provided shows that:
• the biosimilar and the reference biological are highly similar
• there are no clinically meaningful differences in efficacy and safety between the biosimilar and the reference biological.

Once authorized, as for all biologicals, Health Canada issues a Notice of Compliance (NOC) and a unique Drug Identification Number (DIN). Biosimilars are not always authorized for all of the same indications as for the reference biological [2]. Reasons for differences can include patent protection on certain indications and lack of evidence in a certain indication.

Following a number of stakeholder consultations including the 2018 Consultation on the Naming of Biologic Drugs [3], Health Canada decided that biologicals, including biosimilars, will be identified by their unique brand name and non-proprietary (common) name, without the addition of a product-specific suffix [4].

Related articles
Biosimilars regulation in Canada: state of play

Biosimilars approved in Canada

Canadian guidelines for biosimilars

References
1. GaBI Online - Generics and Biosimilars Initiative. Canadian guidelines for biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Dec 6]. Available from: www.gabionline.net/Guidelines/Canadian-guidelines-for-biosimilars
2. GaBI Online - Generics and Biosimilars Initiative. Health Canada approves Inflectra biosimilar for extra indications [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Dec 6]. Available from: www.gabionline.net/Biosimilars/News/Health-Canada-approves-Inflectra-biosimilar-for-extra-indications
3. GaBI Online - Generics and Biosimilars Initiative. Online consultation on biological drug naming in Canada [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Dec 6]. Available from: www.gabionline.net/Policies-Legislation/Online-consultation-on-biological-drug-naming-in-Canada
4. GaBI Online - Generics and Biosimilars Initiative. Health Canada announces naming convention for biologicals [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Dec 6]. Available from: www.gabionline.net/Policies-Legislation/Health-Canada-announces-naming-convention-for-biologicals

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Source: Health Canada

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