Today, AbbVie filed a complaint against Boehringer Ingelheim (BI) in the U.S. District Court for the District of Delaware regarding BI’s aBLA for a biosimilar version of AbbVie’s Humira…
Today, AbbVie filed a complaint against Boehringer Ingelheim (BI) in the U.S. District Court for the District of Delaware regarding BI’s aBLA for a biosimilar version of AbbVie’s Humira…
Yesterday, two groups announced the submission of applications seeking FDA approval of biosimilars of Herceptin® (trastuzumab), which is indicated for the treatment of HER2-positive early…
Earlier this week Coherus filed a motion to stay the BPICA litigation brought by Amgen in the District of Delaware, arguing that in light of the FDA’s complete response letter…
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…