Sandoz Tested Erelzi’s Suffix On Multiple Fronts

Evaluations of potential nonproprietary name suffixes for the US biosimilar to Amgen’s Enbrel included checks on Internet search engines and databases of abbreviations and proprietary names, as well as safety, trademark and phonetic analyses.

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 suffixes for Erelzi, which references Amgen’s TNF-inhibitor Enbrel (etanercept), due...

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