Merck brings its years of experience in quality healthcare to the biosimilars arena.
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A biosimilar is a biologic drug that enters the market after the innovator biologic and has a demonstrated similarity to the innovator biologic.1
A demonstration of similarity does not signify that the quality attributes are identical. They are highly similar, with two results:1
* Clinical significance unknown.
† For the 12 months ending December 2017.
§ Price difference varies from product to product.
1Health Canada. Guidance Document: Information and Submission Requirements for Biosimilar Biologic Drugs. Revised November 14, 2016. Available online: https://www.canada.ca/content/dam/hc-sc/migration/hc-sc/dhp-mps/alt_formats/pdf/brgtherap/applic-demande/guides/seb-pbu/seb-pbu-2016-eng.pdf Accessed April 6, 2018.
2Health Canada. Drugs and Health Products. Fact Sheet: Biosimilars. Available at: http://www.hc-sc.gc.ca/dhp-mps/brgtherap/applic-demande/guides/biosimilars-biosimilaires-qa-qr-eng.php. Accessed on April 9, 2018.
3IQVIA. PharmaFocus 2021 Update. Dec. 2017.
4CADTH. Biosimilar Drugs. February 2017.
5CADTH. Subsequent Entry Biologics – Emerging Trends in Regulatory and Health Technology Assessment Frameworks. Environmental Scan, Issue 43, January 2014
6PMPRB (Patented Medicine Prices Review Board). Potential Savings from Biosimilars in Canada. 2017. http://www.pmprb-cepmb.gc.ca/view.asp?ccid=1304. Accessed April 8, 2018.
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