Biosimilar Name Debate Heats Up As USP Says Zarxio Doesn't Need Suffix
Determination that Zarxio meets monograph standards indicates product should carry same nonproprietary name as Neupogen, USP argues; FDA says monograph doesn't apply.
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Woodcock: Concerns About US FDA's Biosimilars Suffix Policy Detached From Reality
In an exclusive interview, Center for Drug Evaluation and Research Director Janet Woodcock contends that industry concerns about FDA's new suffix policy aren't reflective of real-world problems.
Policy Reversal: FDA Will No Longer Require Suffixes For Older Biologics
New US FDA draft guidance says that the agency will no longer change the proper names of originator biologics to include a four-letter suffix, although the agency will continue to attach suffixes to future approvals.
FDA Claims Sole Authority Over Naming Of US-Licensed Biologics
Deferring to nonproprietary names established by US Pharmacopeia without exercising independent judgment ‘would be untenable,’ FDA says in citizen petition response to industry; agency offers statutory defense of decision to require distinguishable suffixes for all novel biologics and biosimilars.