publication date: Sep. 11, 2015

What’s in a Suffix? FDA’s Dilemma: How to Name Biologics

 

 

After a courtroom victory against Amgen Inc. this summer, the last of the obstacles was removed for the first biosimilar agent—a white blood cell growth factor—to enter the U.S. market.

Zarxio (filgrastim-sndz), sponsored by Sandoz Pharmaceuticals, a unit of Novartis, appeared on the U.S. market Sept. 3, offering a lower-priced alternative to the branded product, Neupogen.

With biosimilars about to appear on the market, FDA is preparing to reconsider the manner in which these agents—as well as the reference products they copy—are named.

Days before the biosimilar agent became available, on Aug. 28, FDA published a guidance to industry and a related rule that propose changes in the way non-proprietary, or generic, biologics are named. Under the agency’s plans, the Sandoz agent would lose the suffix “sndz,” an obvious abbreviation for the name of its sponsor, and the Amgen drug would acquire a new suffix.

According to FDA’s proposals, the branded filgrastim, which has been on the U.S. market since 1991, would become filgrastim-jcwp and the Sandoz agent would become filgrastim-bflm.

The agency’s rationale for assigning suffixes that have no meaning:

“The placement of the identifier as a suffix should result in an originator product, a related biological product, and a biosimilar product being grouped together in electronic databases, yet remaining distinguishable, which should help health care providers identify these products.

Continue reading 41-33 What’s in a Suffix? FDA’s Dilemma: How to Name Biologics

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