Posted by Michael Wonder on 29 Jun 2016
Sandoz Canada regulatory submission for subsequent entry biologic etanercept accepted for review by Health Canada
28 June 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.
Sandoz biosimilar etanercept was accepted by the FDA and EMA for regulatory review in the last quarter of 2015.
Last year, Sandoz Canada received approval from Health Canada for a number of additional indications for Omnitrope, a recombinant human growth hormone used to treat growth problems in both pediatric and adult patients. Omnitrope was Canada's first biosimilar.
