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Where’s The Suffix? Valeant’s Siliq Approved Without Four-Letter Identifier

 
• By Michael Cipriano

Psoriasis treatment brodalumab is first novel biologic approved since US FDA released its final guidance on nonproprietary naming for new biologics and biosimilars; agency says it didn't want to delay the approval by taking more time to develop a suffix.

The US FDA gave its blessing to Valeant Pharmaceuticals International Inc.'s psoriasis treatment Siliq (brodalumab), but without a four-letter suffix the agency said it would require for novel biologics and biosimilars.

A monoclonal antibody, brodalumab was approved Feb. 15 for the treatment of adults with moderate to severe plaque psoriasis. The...

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