Sandoz’s Biosimilar Data-Bridging Plans For <em>Zarxio</em> Faced FDA Doubts

Sandoz’s Biosimilar Data-Bridging Plans For Zarxio Faced FDA Doubts

15 Jun 2015

FDA 'strongly encouraged' Sandoz to conduct three-way clinical PK/PD study comparing its Zarxio biosimilar to the EU- and U.S.-approved versions of Amgen’s Neupogen; however, the firm succeeded in using only analytical data to justify relevance of studies using the European reference product.

Sandoz Inc.’s success at building an analytical bridge to foreign comparator data for its biosimilar Zarxio (filgrastim-sndz) may prove to be the exception rather than the rule for biosimilar development programs conducted with non-U.S. reference products.

The March 6 approval of Zarxio, a biosimilar to Amgen Inc.’s granulocyte colony-stimulating factor Neupogen (filgrastim), showed it is...