We previously reported, Amgen filed a BPCIA suit against Coherus Biosciences, Inc., relating to its aBLA for its pegfilgrastim (Neulasta®) biosimilar. In response, Coherus filed a motion to dismiss the suit arguing that Amgen’s complaint failed to state a plausible claim of infringement.

On June 12, 2017, we also reported that Coherus received a complete response letter (“CRL”) from the FDA for its pegfilgrastim biosimilar application. The CRL contained a “request for a reanalysis of a subset of subject samples with a revised immunogenicity assay, and requests for certain additional manufacturing related process information.”

Yesterday, in light of the FDA’s CRL, Coherus filed a motion to stay the litigation with Amgen.  Coherus’ motion states, “Coherus estimates that the FDA’s rejection will most likely delay launch of [its pegfilgrastim] product by approximately one year. … Since receiving the FDA’s rejection, Coherus already has laid off one-third of its workforce to preserve its cash.” Coherus has asked the Court to consider these developments and stay discovery in the case while the Court considers Coherus’ motion to dismiss as to avoid “unnecessary litigation expenses,” which could potentially “bankrupt Coherus.”

Coherus has also filed a motion to stay a separate suit by Amgen in the California state Superior Court relating to Coherus’s pegfilgrastim application.  A hearing on the motion to stay the state court litigation is scheduled for August 10, 2017.