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1. • Unique brand name and non-proprietary (common) name

     • Following internal and external stakeholder consultations and analysis of related issues, Health Canada has decided that biologic drugs, including biosimilars, will be identified by their unique brand name and non-proprietary (common) name, without the addition of a product-specific suffix.
     www.canada.ca › en › health-canada

     Notice to Stakeholders - Policy Statement on the Naming of ...

2. People also ask

   Are biosimilars legal in Canada?

   • Health Canada authorizes biosimilars for sale using the same rigorous regulatory standards for quality, efficacy and safety as for all other biologic drugs. Biologic drugs come from living organisms or from their cells. They are often made using biotechnology. Examples of biologic drugs include insulin, growth hormones and antibodies.

   Biosimilar biologic drugs in Canada: Fact Sheet - Canada.ca

   www.canada.ca/en/health-canada/services/drugs-health-products/biologics-radiopharmaceuticals-genetic-therapies/applications-submissions/guidance-documents/fact-sheet-biosimilars.html

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   Do biosimilars need a unique brand name?

   • To facilitate product-level identification of biologic drugs, including biosimilars, Health Canada recommends that the unique brand name and the non-proprietary name as well as other product-specific identifiers, such as the DIN and the lot number, be used throughout the medication use process.

   Biosimilar biologic drugs in Canada: Fact Sheet - Canada.ca

   www.canada.ca/en/health-canada/services/drugs-health-products/biologics-radiopharmaceuticals-genetic-therapies/applications-submissions/guidance-documents/fact-sheet-biosimilars.html

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   What is a biosimilar drug?

   • A biosimilar is a biologic drug that is highly similar to a biologic drug that was already authorized for sale. Health Canada authorizes biosimilars for sale using the same rigorous regulatory standards for quality, efficacy and safety as for all other biologic drugs. Biologic drugs come from living organisms or from their cells.

   Biosimilar biologic drugs in Canada: Fact Sheet - Canada.ca

   www.canada.ca/en/health-canada/services/drugs-health-products/biologics-radiopharmaceuticals-genetic-therapies/applications-submissions/guidance-documents/fact-sheet-biosimilars.html

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   Can a biosimilar be used as a reference biologic drug?

   • Once studies show that the biosimilar is highly similar to the reference biologic drug with no clinically meaningful differences, Health Canada can authorize the biosimilar for the same indications as the reference biologic drug, based on the previously-established efficacy and safety of the reference biologic drug in each indication.

   Biosimilar biologic drugs in Canada: Fact Sheet - Canada.ca

   www.canada.ca/en/health-canada/services/drugs-health-products/biologics-radiopharmaceuticals-genetic-therapies/applications-submissions/guidance-documents/fact-sheet-biosimilars.html

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3. www.canada.ca › en › health-canadaBiosimilar biologic drugs in Canada: Fact Sheet - Canada.ca

   www.canada.ca › en › health-canada

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   Naming convention for biologic drugs including biosimilars. The naming convention for biologic drugs, including biosimilars, consists of a unique brand name, as well as the non-proprietary (common/proper) name, without the addition of a product-specific suffix.

4. www.ncbi.nlm.nih.gov › pmc › articlesRegulatory challenges with biosimilars: an update from 20 ...

   www.ncbi.nlm.nih.gov › pmc › articles

   Nov 21, 2020 · Exceptions to this are: Canada, which established policy on this in 2019 (“Notice to Stakeholders‐Policy Statement on the Naming of Biologic Drugs”); Iran, which adopted a regulation for naming of pharmaceutical products in 2013; and Japan, which finalized nomenclature rules in 2013.

   • Author: Hye Na Kang, Robin Thorpe, Ivana Knezevic, Mary Casas Levano, Mumbi Bernice Chilufya, Parichard Chir...

   • Publish Year: 2021

5. globalforum.diaglobal.org › issue › may-2019Biosimilars in Canada: Regulatory and Health System Approaches

   globalforum.diaglobal.org › issue › may-2019

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   Megan Bettle. Health Canada. B. iologic drugs account for a large proportion of Canadian drug spending. As in many other countries, the development of a robust biosimilars market is looked at by Canadian drug payers as one way to support healthcare budget sustainability.

6. ask-biosimilars.com › wp-content › uploadsBIOSIMILAR REGULATION IN CANADA

   ask-biosimilars.com › wp-content › uploads

   BIOSIMILAR REGULATION IN CANADA. This document summarises the national regulatory guidance on biosimilar medications in Canada. It is intended as a concise summary of the key guidance for biosimilar regulation and approval, available to download and share with your multidisciplinary team.

7. biosimilars.jointhealth.org › wp-content › uploadsBiosimilar biologics in Canada Transitioning to a biosimilar ...

   biosimilars.jointhealth.org › wp-content › uploads

   Health Canada has approved more than 33 biosimilars to help treat Canadians living with inflammatory arthritis, cancer, diabetes, inflammatory bowel disease and psoriasis. Biologic drugs make up some of public and private drug plans’ largest drug expenditures.

8. www.smartbiggar.ca › insights › publicationUpdate on biosimilars in Canada – March 2024

   www.smartbiggar.ca › insights › publication

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   Mar 25, 2024 · Health Canada has approved four biosimilars since our last update: Baxter’s AXBERI and AXBERI HP, biosimilars of Sanofi’s LOVENOX and LOVENOX HP (enoxaparin sodium) Teva’s RANOPTO, biosimilar of Novartis’s LUCENTIS (ranibizumab) JAMP Pharma’s JAMTEKI and Amgen’s WEZLANA, biosimilars of Janssen’s STELARA (ustekinumab)