Fourth Biosimilar Developer Settles With Genentech Over Trastuzumab Patents

Samsung Bioepis, developer of the biosimilar trastuzumab, Ontruzant, and Genentech, maker of the reference trastuzumab, Herceptin, have asked a court to dismiss their patent litigation.

Late last month, the 2 companies filed a joint stipulation of dismissal with the United States District Court for the District of Delaware for a Biologics Price Competition and Innovation Act (BPCIA) litigation. According to the stipulation, the companies have entered into a settlement agreement and are voluntarily dismissing all claims and counter claims asserted in the litigation.

The terms of the settlement were not disclosed by either company, and no date for a launch of the biosimilar trastuzumab in the United States has been announced.

The settlement is the fourth known agreement between the Herceptin maker and a biosimilar challenger. Fellow biosimilar maker Mylan, which developed Ogivri with its partner Biocon, also settled with Genentech over Herceptin patents and withdrew its pending inter partes review challenges in 2017.

Additionally, Celltrion and Teva, makers of Herzuma, reached a settlement with Genentech and agreed to dismiss their BPCIA litigation in late 2018.

Pfizer, maker of Trazimera, also settled with Genentech in late 2018.

Launch dates for these biosimilar trastuzumab options have not been publicly disclosed, either; however, Mylan, when it announced its settlement, said that it anticipated being the first company to launch a biosimilar trastuzumab product in the United States.

Meanwhile, 1 remaining developer with an approved biosimilar trastuzumab has not settled with the Herceptin maker: Amgen, which recently received approval for Kanjinti, is currently in a BPCIA dispute with Genentech, and Genentech has reportedly filed a motion for a temporary restraining order and a preliminary injunction against Amgen in the case.