We previously reported that the FDA approved Celltrion’s Inflectra®, a biosimilar to Janssen’s Remicade® (infliximab) on April 5, 2016. A year prior to the approval, Janssen filed a…
We previously reported that the FDA approved Celltrion’s Inflectra®, a biosimilar to Janssen’s Remicade® (infliximab) on April 5, 2016. A year prior to the approval, Janssen filed a…
As we covered in a previous post, following the Federal Circuit’s decision in Amgen v. Sandoz, Sandoz filed a petition for a writ of certiorari asking the Supreme Court to…
The District Court for the District of Massachusetts (Judge Wolf) yesterday decided two pending motions in Janssen v. Celltrion: Plaintiffs’ motion to stay litigation on the ‘471…
As we reported earlier, Amgen recently filed suit under the BPCIA against Sandoz and Lek Pharmaceuticals in the Northern District of California. Amgen alleges that Sandoz’s submission of an aBLA…
Yesterday, Amgen filed suit in an action for patent infringement arising under the Biologics Price Competition and Innovation Act of 2009 (“the BPCIA”), following Sandoz’s submission of an…
In a recent hearing held in Amgen v. Hospira, the parties offered arguments on some novel issues relating to litigation under the BPCIA, particularly: Whether a reference product sponsor…
We previously reported that the FDA approved Celltrion’s Inflectra®, a biosimilar to Janssen’s Remicade® (infliximab). Last week, we also reported that in Janssen v. Celltrion, Janssen…
Attorneys for Amgen and Apotex appeared before the Federal Circuit yesterday to argue about whether the notice of commercial marketing provision, 42 U.S.C. § 262(l)(8)(A), is optional when a…
This is an update on the latest activity before the United States Supreme Court in the ongoing dispute between Amgen and Sandoz regarding Sandoz’s biosimilar application for Zarxio®…
As we posted yesterday, Amgen has filed a brief in opposition to Sandoz’s petition to the Supreme Court for review of the Federal Circuit’s decision in Amgen v. Sandoz. Amgen’s…