Biosimilar But Different: <em>Zarxio</em>, <em>Neupogen</em> Diverge On Syringes, Vials

Biosimilar But Different: Zarxio, Neupogen Diverge On Syringes, Vials

16 Mar 2015

Differences in product presentation may not have much market impact now but could prove a regulatory challenge if Sandoz pursues an interchangeability determination down the line.

Differences in product presentation and patient labeling between Sandoz Inc.’s Zarxio (filgrastim-sndz) and its reference product, Amgen Inc.’s Neupogen (filgrastim), are not expected to impede the biosimilar’s acceptance by health care professionals and patients, but they could create a regulatory hurdle to an eventual determination of interchangeability.

FDA approved Zarxio, the first biosimilar licensed under the 351(k) pathway, on March 6 with all five of the indications...