Amgen has filed a BPCIA suit in the District of Delaware against Coherus Biosciences, Inc., alleging infringement of U.S. Patent No. 8,273,707—a patent “directed to a process for purifying proteins.” The complaint alleges that following FDA’s acceptance of Coherus’s abbreviated biologics application for a biosimilar version of Amgen’s Neulasta® (pegfilgrastim)…
The European Commission recently announced a report on the impact of biosimilar competition on price, volume and market share, based on full-year data from 2016. The report, prepared by QuintilesIMS, analyzed six established therapy areas with biosimilar competition—epoietin (EPO), G-CSF, hGH, anti-TNF, fertility/gonadotropin preparations, and recombinant human insulins—and identified four…
Earlier this week, Celltrion filed two petitions for inter partes review of Genentech’s U.S. Patent No. 6,407,213. According to Celltrion’s petitions, the patent is directed to humanized antibodies. Mylan previously challenged the same patent in two IPR petitions, which terminated in settlement with Genentech. We will continue to monitor and report…
On Thursday, May 4, 2017, Baxalta, a wholly-owned subsidiary of Shire, filed a complaint (available here) against Genentech and Tokyo-based Chugai Pharmaceutical in the U.S. District Court for the District of Delaware. The complaint alleges infringement of Baxalta’s U.S. Patent No. 7,033,590, which Baxalta alleges covers the defendants’ emicizumab product (a/k/a…
Merck Sharpe & Dohme and Genentech have filed a Joint Motion to Terminate IPR2016-00710, relating to U.S. Patent No. 6,331,415. As we reported earlier, the ‘415 patent is known as one of the “Cabilly” patents, and is generally applicable to manufacturing recombinant antibodies. According to the motion, the parties have reached…
As we previously reported, in Janssen v. Celltrion, Janssen appealed the district court’s partial final judgment that Janssen’s ’471 patent, relating to monoclonal antibodies including infliximab, is invalid. As we also previously reported, Janssen filed its opening appeal brief on January 26, 2017. On March 7, 2017, Celltrion filed its response brief. On April 20,…
The World Health Organization (WHO) announced today plans to launch a pilot project for prequalifying biosimilar medicines later this year. The project will initially focus on biosimilar versions of two cancer treatments, rituximab and trastuzumab, with possible expansion into prequalifying insulin. WHO will begin accepting applications this September and will…
The Korea Herald reports that Celltrion is on track to file applications for U.S. FDA approval for its rituximab and trastuzumab biosimilars by June. According to the article (and as previously reported), once approved, the drugs will be sold through Celltrion’s U.S. commercial partner, Teva Pharmaceutical Industries Ltd.
Generic drugs currently account for 88% of all U.S. prescriptions, yielding 10-year cost savings in excess of $1.5 trillion. There is some optimism that biosimilars will offer a similar low-cost therapeutic alternative to branded biologics. However, the Journal of the American Medical Association (JAMA) has recently published an article discussing…
On April 27, 2017, The Korea Herald and The Investor reported that Celltrion and Nippon Kayaku entered into an agreement under which Nippon Kayaku will sell Truxima, Celltrion’s biosimilar of Rituxan, in Japan. According to the articles, Nippon Kayaku has exclusive rights to sell Celltrion’s Truxima, Remsima and Herzuma, and the…