FDA Issues Complete Response Letter for Sandoz’s Neulasta® Biosimilar

As we’ve previously reported, Sandoz is seeking approval of an aBLA for its proposed biosimilar to Neulasta® (pegfilgrastim), which is currently the subject of a BPCIA litigation (Civil Action No. 3:16-cv-02581 (N.D. Cal.))  against Amgen, the reference product sponsor.  Today, Sandoz announced that it has received a complete response letter from the FDA and that Sandoz is “working with the agency to address remaining questions.”

Stay tuned to the Big Molecule Watch for updates on Sandoz’s aBLA and the related litigation.