We previously reported on Regeneron’s antitrust suit against Amgen in the U.S. District Court for the District of Delaware. Amgen recently filed a motion to dismiss Regeneron’s Complaint and a motion to stay the case. The case concerns Regeneron’s allegation that Amgen has violated antitrust law by engaging “in a…
On September 20, 2021, the FDA issued a revised final guidance for industry entitled “Questions and Answers on Biosimilar Development and the BPCI Act” and a third revision to its draft guidance entitled “New and Revised Draft Q&As on Biosimilar Development and the BPCI Act.” According to FDA, the guidance…
Last week, FDA announced the Biosimilar User Fee Act (BsUFA) rates for the 2022 fiscal year, which runs from October 1, 2021 through September 30, 2022. The FDA determined these rates pursuant to the Food and Drug Administration Reauthorization Act (FDARA), which was signed into law on August 18, 2017….
On November 12, 2020, Genentech filed a complaint in the Eastern District of Texas alleging that the Centus Biotherapeutics, Ltd., Fujifilm Kyowa Kirin Biologics Co., Ltd., Fujifilm Corp., and Kyowa Kirin Co, Ltd. (collectively, Centus) proposed biosimilar to Genentech’s AVASTIN (bevacizumab) product infringes 10 U.S. patents. Yesterday, the parties filed a Joint…