Last night, Genentech filed a motion for a temporary restraining order and a motion for a preliminary injunction against Amgen in the Genentech v. Amgen BPCIA litigation related to Amgen’s trastuzumab biosimilar KANJINTI (trastuzumab-anns). Genentech’s motion papers were filed under seal, and Amgen’s responsive papers on the preliminary injunction motion are due July 24, 2019 per the local rules.
As we previously reported, on June 13, 2019 Amgen received FDA approval for KANJINTI (trastuzumab-anns), making it the fifth trastuzumab biosimilar to obtain FDA approval.