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…
With the Supreme Court’s pending decision in Sandoz v. Amgen, the interpretation of the patent dance provisions of the BPCIA has been a hot topic here on the blog. For an in-depth analysis of patent dance strategies employed by biosimilar applicants to date, check out this article in Bloomberg’s Life Sciences…
In the past few days, Pfizer has filed petitions for IPR of two of Biogen’s patents related to rituximab: IPR2017-01166 on U.S. Patent 8,329,172 and IPR2017-01167 on U.S. Patent 8,577,244. According to the petitions, the patents are directed to methods of treating non-Hodgkin’s Lymphoma with rituximab. The petitions are posted…
Last week, Apotex filed a Citizen Petition requesting that FDA “take certain actions to ensure a robust approval process” for proposed biosimilars to Amgen’s Neulasta (pegfilgrastim). Among its requests, Apotex asks that FDA require each biosimilar applicant to conduct comparative clinical efficacy studies, including pharmacokinetics, pharmacodynamics, and immunogenicity studies, in at least…