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FDA Biosimilar Policy Continues To Evolve With Approval Of Sandoz Erelzi

 
• By Nielsen Hobbs

Third biosimilar approved in US brings another iteration of FDA thinking on labeling and naming; etanercept-szzs, which references Amgen's Enbrel, suggests agency might be backtracking on its suffix policy.

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"Szzs" is probably a combination of letters only a linguist could love. But for sponsors hoping that FDA might change its policy on suffixes for biosimilars, it’s a syllable in the right direction. The Aug. 30 approval of Sandoz Inc.'s Erelzi (etanercept-szzs) means that the agency has now used three different approaches for adding suffixes for each of the three biosimilars it has approved – going from meaningful to random and now back toward somewhat meaningful.

Erelzi, which references Amgen Inc.'s TNF inhibitor Enbrel (etanercept), is Sandoz's second biosimilar approved in the US. The company's...

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