Biosimilars Naming Policy Could Come by End of Year

Wednesday, May 6, 2015

Source: FDA News

The FDA says it plans to provide guidance by year’s end on naming biosimilars, potentially ending much of the confusion over how the products will be labeled and tracked.

The naming guidance is one of six topics added to the agency’s 2015 guidance agenda last week — bringing to 98 the number of new and revised draft guidances CDER hopes to publish this year.

Biosimilars naming has been a hot button issue among brand and biosimilars makers. GPhA and some generics makers have argued that biosmilars need no name qualifiers and should be treated as same-name generic therapies because, in the U.S. at least, approval is based on showing that they have no clinically meaningful differences from the reference product.

In March, the FDA approved Sandoz’s Zarxio biosimilar of Amgen’s blockbuster chemotherapy product Neupogen (filgrastim) using the placeholder name filgrastim-sndz. It’s still not clear whether manufacturers will be able to propose unique names or if the agency will ask them to conform to the international nonproprietary naming system.

View All News »