Federal Circuit Denies Amgen’s Request to Block Zarxio Launch

By a two to one vote, a Federal Circuit Court of Appeals panel cleared the way for Sandoz’s launch of Zarxio, the first FDA-approved biosimilar, as early as today.

In an eleventh hour ruling, the three-judge panel denied, without comment, reference product maker Amgen’s request for an emergency injunction pending a full court review of a July panel decision allowing Zarxio (filgrastim-sndz) to launch after Sept. 2.

Amgen, which is seeking to delay competition to its blockbuster chemotherapy product Neupogen (filgrastim), claims the July panel erred when it declared biosimilar makers aren’t compelled to disclose relevant patent information to the reference product maker.

Sandoz argued that Amgen’s request for an emergency injunction did not meet the required legal standard. — John Bechtel