Valeant's New Biologic Lacks Required FDA Suffix

Feb 19, 2017


The U.S. FDA just approved a new biologic from Valeant Pharmaceuticals, but its name did not adhere to the recent guidance requiring all new and previously approved biologics and biosimilars to have a four-letter random suffix attached to their nonproprietary names, according to Regulatory Affairs Professional Society (RAPS).

“This week’s biologic, Siliq (brodalumab), was licensed under section 351(a) of the Public Health Service Act, and thus is within the scope of our recently issued guidance on the Nonproprietary Naming of Biological Products,” an agency spokesperson told Focus.

“However, FDA issued the final guidance [on Jan. 12] at a point in our review of the application that did not allow sufficient time for FDA to designate a proper name that includes a suffix as described in the guidance. In order to avoid delaying the approval of brodalumab and in the interest of public health, FDA licensed the biological product with a designated proper name that did not include a suffix...”

Read the full RAPS story