As we reported in a previous post, Amgen is the plaintiff in another suit litigating the patent information provisions of the BPCIA, this time against Hospira. Amgen’s complaint alleged…
As we reported in a previous post, Amgen is the plaintiff in another suit litigating the patent information provisions of the BPCIA, this time against Hospira. Amgen’s complaint alleged…
Momenta and Baxalta have announced a global clinical trial to study the safety, efficacy and immunogenicity of M923, a biosimilar to AbbVie’s Humira (adalimumab). The trial is intended to support…
As we’ve reported previously, the parties in Amgen v. Apotex have completed the first wave of the BPCIA patent dance and are now litigating the first round of patent infringement…
On October 5, 2015, Apotex filed its answer and counterclaims in the ongoing Amgen v. Apotex Neulasta® (pegfilgrastim) litigation. As we previously reported, Amgen’s complaint alleged that Apotex…
Last updated: November 28, 2016 Below is a summary of the BPCIA litigations that have been filed to date. Please also read our quarterly BPCIA litigation round-up posts for additional…
Amgen and Allergan announced their biosimilar candidate ABP 215 “met its primary and secondary endpoints” in a Phase 3 study by demonstrating “clinical equivalence in efficacy, and comparable…
As we’ve covered in previous posts (here and here), the parties in Janssen v. Celltrion have been supplementing their briefings on whether Celltrion’s notice of commercial marketing, given…
As we reported previously, Amgen and Sandoz filed a joint motion to lift the stay of proceedings on Amgen’s patent infringement claims and Sandoz’s related counterclaims in the U.S. District…
Amgen has initiated new litigation over the patent provisions of the BPCIA, this time against Hospira in the U.S. District Court for the District of Delaware, regarding Hospira’s biosimilar…
Complaint Hospira’s Motion to Dismiss Count I and Count II Amended Complaint Hospira’s Letter to the Court re: Hospira’s Motion to Dismiss Hospira’s Motion to Dismiss Count…