This past April, the FDA approved Inflectra® (infliximab-dyyb), Celltrion and Hospira’s biosimilar of Janssen’s Remicade®. According to papers filed in the Federal Circuit this week, Celltrion and Hospira (collectively, “Celltrion”) have now launched Inflectra® in the United States. On December 6, Celltrion stated that it “recently launched in the United States,” and Janssen asserted yesterday that “Celltrion began U.S. sales on November 28, 2016.” The timing of this launch is consistent with prior representations by Pfizer (Hospira’s parent) that it would begin shipping Inflectra® to wholesalers in late November. Inflectra® is just the second biosimilar product approved under the BPCIA to be launched in the United States—the first being Sandoz’s Zarxio® (filgrastim-sndz).
These papers were filed in connection with Janssen’s appeal from the Massachusetts District Court’s judgment that the ’471 patent is invalid for obviousness-type double patenting (Fed. Cir. Case No. 17-1120). Janssen’s opening brief on the merits of its appeal currently is due on December 27, 2016, though Janssen is seeking a 30-day extension of time.
Janssen’s is also pursuing a separate Federal Circuit appeal (Fed. Cir. Case No. 17-1257) from the Patent Trial and Appeal Board’s November 14, 2016 decision affirming a USPTO examiner’s final rejection of the claims of the ’471 patent for obviousness-type double patenting in an ex parte reexamination of that patent. Janssen’s opening brief in that appeal is due January 23, 2017.
Stay tuned to Big Molecule Watch for further developments.