According to Business Wire, on September 12, 2016, Samsung Bioepis announced that it has added Canada to its growing list of jurisdictions in which it has received regulatory approval for…
According to Business Wire, on September 12, 2016, Samsung Bioepis announced that it has added Canada to its growing list of jurisdictions in which it has received regulatory approval for…
The District Court for the Southern District of Florida today ruled that Apotex’s proposed filgrastim and pegfilgrastim products will not infringe the asserted claims of Amgen’s ’138 patent…
A couple of updates on Amgen v. Hospira (epoetin alfa): Amgen has requested that the district court (D. Del., J. Andrews) grant it leave to file a second amended complaint…
The FDA today approved Sandoz’s application for a biosimilar version of Amgen’s Enbrel product (etanercept). Sandoz’s biosimilar is called Erelzi. It is the first biosimilar…
Below is a brief summary of each of the U.S. patent litigations concerning a proposed or approved biosimilar product. Please also consult our BPCIA Litigation Summary Chart for…
As we reported, in a litigation regarding Hospira’s planned biosimilar for Amgen’s epoetin alfa, sold under the brand names Epogen and Procrit, in May, 2016, the District Court (D.Del.,…
On August 5, Apotex filed a petition for an IPR on Patent No. 8,952,138, owned by Amgen. The ’138 patent is the same patent that is being challenged in the…
A few BPCIA litigation updates to wrap up the week for our readers, looking ahead to next week: The Federal Circuit issued its formal mandate in Amgen v. Apotex yesterday….
As we previously reported, on July 20, the Southern District of Florida granted Amgen’s motion for judgment on partial findings that the ’138 patent was not proven invalid on grounds…
Mylan N.V. and Biocon Ltd. recently announced that the European Medicines Agency has accepted Mylan’s Marketing Authorization Application for a proposed biosimilar version of Amgen’s Neulasta…