Biosimilars Facts

Biosimilars Facts
How are biosimilars authorized for use?

To obtain Health Canada’s authorization to sell a biosimilar, manufacturers must independently demonstrate the quality of the medicine and perform comparative studies to demonstrate highly similar structure, function, efficacy and safety to a previously authorized original-brand biologic.13

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Biosimilars Facts
Starting on a biologic (original-brand or biosimilar)

The decision to start on a biologic – original-brand or biosimilar - should be made by a well-informed patient and their healthcare professional based on the available clinical evidence.

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Biosimilars Facts
Biosimilars: Frequently Asked Questions

Here are answers based on the latest scientific and real-world experience to Frequently Asked Questions (FAQs) about biosimilar medicines from patients and healthcare providers. Please refer to Biosimilars Glossary for definition of key terms.

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13 Health Canada Biosimilars Fact Sheet:
https://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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