On Friday, March 4, 2016, Amgen filed a complaint (available here) seeking a declaratory judgment in the U.S. District Court for the District of New Jersey against Sandoz. The complaint…
On Friday, March 4, 2016, Amgen filed a complaint (available here) seeking a declaratory judgment in the U.S. District Court for the District of New Jersey against Sandoz. The complaint…
A jury trial starts Monday, March 7, in the patent case between plaintiff Amgen Inc. and defendants Sanofi and Regeneron over two biologic drugs, Amgen’s Repatha and Sanofi/Regeneron’s Praluent….
Amgen, Hoffmann-La Roche and Immunex have filed a complaint in the District of New Jersey against Sandoz alleging patent infringement of the plaintiffs’ etanercept (ENBREL) patents under the…
Last week, Judge Richard Andrews in the District of Delaware heard argument in Amgen v. Hospira on Hospira’s motion to dismiss Amgen’s action over notice provisions in the Biologics Price…
The Federal Circuit announced that oral argument for the Amgen v. Apotex appeal will be held on April 4, 2016. Apotex is seeking to overturn the district court’s injunction against…
Sandoz has filed a petition for a writ of certiorari, asking the Supreme Court to review the Federal Circuit’s interpretation of the BPCIA’s “notice of commercial marketing” provision….
Apotex has filed its reply brief in Amgen v. Apotex, which is currently on appeal before the Federal Circuit. The brief is available here. As we covered previously, the district…
Biocon, a prominent Indian biopharma company, entered into a partnership with Mylan in 2009 for joint research and development of biosimilars. That partnership now appears to be yielding…
Today, Sandoz announced that the EMA has accepted its Marketing Authorization Application for its biosimlar to Amgen’s Neulasta, used to prevent infection in patients with compromised immune…
Yesterday, the FDA’s Advisory Committee overwhelmingly supported approval of Celltrion’s infliximab product, which is a biosimilar for Janssen’s Remicade product. At the District Court…