Biosimilars Await Naming Guidance From FDA

Sandoz's biosimilar will be sold under the trade name Zarxio but the FDA has held off on releasing a naming policy for biosimilars, giving the product a "placeholder nonproprietary name" of "filgrastim-sndz."

Earlier this month, the FDA announced the first approval of a biosimilar product under the Biologics Price Competition and Innovation Act (BPCIA). The new Sandoz product, which will be sold under the trade name Zarxio, is a biosimilar of Amgen’s Neupogen (filgrastim) product. The FDA has, however, held off on releasing a naming policy for biosimilars, giving the product a “placeholder nonproprietary name” of “filgrastim-sndz.”

The FDA has stated that this placeholder name “should not be viewed as reflective of the agency’s decision on a comprehensive naming policy for biosimilar and other biological products” and that the agency intends to issue naming guidance in the “near future.”

Read more at Biologics Blog: http://bit.ly/1FycpNd