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Biosimilar Name Debate Heats Up As USP Says Zarxio Doesn't Need Suffix

 
• By Derrick Gingery

Determination that Zarxio meets monograph standards indicates product should carry same nonproprietary name as Neupogen, USP argues; FDA says monograph doesn't apply.

The US Pharmacopeia potentially has thrown another wrench into the biosimilar naming debate as FDA works to finalize its guidance.

USP, which administers the documents that describe product tests for strength, purity and quality, determined that FDA's first approved biosimilar, Sandoz Inc

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