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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.
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.
Eye on Pharma: Golimumab Biosimilar Update; Korea Approves Denosumab; Xbrane, Intas Collaboration
December 10th 2024Alvotech and Advanz Pharma have submitted a European marketing application for their golimumab biosimilar to treat inflammatory diseases, while Celltrion secured Korean approval for denosumab biosimilars, and Intas Pharmaceuticals partnered with Xbrane Biopharma on a nivolumab biosimilar.
Biosimilars in America: Overcoming Barriers and Maximizing Impact
July 21st 2024Join us as we explore the complexities of the US biosimilars market, discussing legislative influences, payer and provider adoption factors, and strategies to overcome industry challenges with expert insights from Kyle Noonan, PharmD, MS, value & access strategy manager at Cencora.
The Rebate War: How Originator Companies Are Fighting Back Against Biosimilars
November 25th 2024Few biologics in the US have multiple biosimilar competitors, but originator biologics respond quickly to competition by increasing rebates and lowering net prices, despite short approval-to-launch timelines for biosimilars.
Decoding the Patent Puzzle: Navigating the Legal Landscape of Biosimilars
March 17th 2024On this episode of Not So Different, Ha Kung Wong, JD, an intellectual patent attorney and partner at Venable LLP, details the confusing landscape that is the US patent system and how it can be improved to help companies overcome barriers to biosimilar competition.
Overcoming Challenges to Improve Access and Reduce Costs
November 12th 2024Biosimilars hold the potential to dramatically lower health care costs and improve access to life-changing treatments, but realizing this potential will require urgent policy reforms, market competition, and better education for both providers and patients.
