As we previously reported, following the Supreme Court’s decision in Sandoz v. Amgen, Sandoz requested a remand to the District Court to answer the two questions that the Supreme Court…
As we previously reported, following the Supreme Court’s decision in Sandoz v. Amgen, Sandoz requested a remand to the District Court to answer the two questions that the Supreme Court…
We previously reported, Amgen filed a BPCIA suit against Coherus Biosciences, Inc., relating to its aBLA for its pegfilgrastim (Neulasta®) biosimilar. In response, Coherus filed a motion to…
Today, the District of Delaware reassigned the AbbVie v. Amgen (adalimumab) litigation from retiring Senior Judge Sue L. Robinson to a visiting judge, Judge Mitchell S. Goldberg of the Eastern…
Sandoz has filed a petition for inter partes review of AbbVie’s U.S. Patent No. 8,802,100 (IPR2017-01823), which claims stable formulations of an anti-TNFα antibody identified in the petition…
The FDA Oncologic Drugs Advisory Committee (ODAC) unanimously supported biosimilar versions of Roche’s cancer drugs Avastin (bevacizumab) and Herceptin (trastuzumab). Amgen and…
On July 12, 2017, Amgen filed a Notice of Withdrawal of its Motion for Preliminary Injunction. As we previously reported, Amgen had filed an amended opening brief in support of…
On July 6, 2017, Hospira filed a publically available redacted version of its brief responding to Amgen’s motion for a preliminary injunction (PI). As we previously reported, following the…
On Wednesday, July 12, 2017, Goodwin’s Elaine Blais will present as a featured speaker during the one-hour webinar, “Who Will ‘Dance’ Now? Biosimilars After Amgen v….
On July 6, 2017, the PTAB issued two additional Final Written Decisions finding AbbVie’s U.S. Patent 8,889,135 (“the ‘135 patent”) unpatentable as obvious over the prior…
On July 5, 2017, Daiichi Sankyo Company announced that it has decided to discontinue the development of CHS-0214, an investigational biosimilar to Amgen’s Enbrel® (etanercept), in Japan. Daiichi…