Sandoz Inc.’s defense of its preferred nonproprietary name suffixes for the biosimilar Erelzi (etanercept-szzs) included a list of analyses conducted to ensure the distinguishable modifiers did not run afoul of FDA guidelines.
As was the case with Amgen Inc.’s biosimilar Amjevita (adalimumab-atto), Sandoz ran into objections from FDA over its proposed...