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Sandoz Canada Regulatory Submission for Subsequent Entry Biologic Etanercept Accepted for Review by Health Canada [1]

Publish Date: 
Jun 28, 2016

Boucherville, QC, June 28, 2016 – Sandoz Canada announced today that Health Canada has accepted for review its regulatory submission for a subsequent entry biologic version (also known as biosimilar) of etanercept, a tumor necrosis factor alpha (TNF-alpha) inhibitor. Subsequent entry biologics are follow-on versions of original biological molecules and undergo their own confirmatory clinical safety and efficacy studies as the final part of a comprehensive comparability exercise.

Read More [2]


Source URL: https://www.sandoz.ca/en/node/20891

Links
[1] https://www.sandoz.ca/en/node/20891
[2] https://prod.sandoz.ca/sites/www.sandoz.ca/files/n_prod_1774346.pdf