On December 6, 2019, the Federal Circuit will hear oral argument in a rituximab-related appeal by Biogen. The appeal stems from a final written decision of the Patent Trial and…
On December 6, 2019, the Federal Circuit will hear oral argument in a rituximab-related appeal by Biogen. The appeal stems from a final written decision of the Patent Trial and…
On November 22, 2019, the parties in the Amgen v. Kashiv BPCIA litigation, concerning Kashiv’s proposed biosimilar of NEUPOGEN (filgrastim), submitted a stipulation of dismissal indicating that…
On November 14, 2019, the parties in the Amgen v. Accord (previously Apotex) follow-on BPCIA litigation filed a Stipulation of Dismissal, agreeing “to the dismissal, without prejudice, of all…
On November 15, the FDA approved Pfizer’s Humira® biosimilar, ABRILADA (adalimumab-afzb). The acting director of the Office of Therapeutic Biologics and Biosimilars in the FDA’s Center for…
On November 7, Bio-Thera Solutions, Ltd. announced that the China National Medical Products Administration (NMPA) approved QLETLI®, a biosimilar to AbbVie’s HUMIRA® (adalimumab). QLETLI® is the…
On October 8, the Institute for Clinical and Economic Review (ICER) published their first report of Unsupported Price Increases (UPIs), aimed at identifying drug price increases that ICER…
As we previously reported, earlier this year Kashiv Biosciences filed two inter partes review (IPR) petitions challenging certain claims of Amgen’s U.S. Patent Nos. 8,940,878 and 9,643,997, which…
On September 20, 2019, the District Court for the District of Delaware endorsed a joint stipulation of the parties to dismiss all claims and counterclaims in the Genentech v. Pfizer…
As we previously reported, Amgen filed a complaint against Adello Biologics and Amneal alleging infringement of several patents, including certain claims of U.S. Patent No. 8,952,138, directed to a…
On September 17, 2019, the U.S. District Court for the Western District of Pennsylvania endorsed the parties’ stipulation and proposed order of non-infringement of U.S. Patent No. 9,643,997…