Last week, the district court in Amgen v. Apotex (No. 18-61828) (S.D. Fla.) denied Apotex’s motion to dismiss Amgen’s complaint in a follow-on suit concerning Apotex’s pegfilgrastim and filgrastim biosimilar candidates. By way of background, Amgen and Apotex have been involved in multiple patent lawsuits regarding Apotex’s pegfilgrastim and filgrastim biosimilars…
On April 5, 2019, Genentech filed patent infringement and declaratory judgment complaint against Pfizer in the District of Delaware in response to Pfizer’s submission of an aBLA seeking U.S. FDA approval of a biosimilar of Avastin® (bevacizumab). In the complaint, Genentech alleges infringement of 22 patents, out of a total…
The FDA has announced that it will hold a hearing to discuss affordability of and access to insulin products, including issues concerning the development of biosimilar and interchangeable insulin products. The hearing will cover scientific standards for evaluating biosimilarity and interchangeability of insulin products; other regulatory considerations, such as whether…
On April 3, 2019, the Board ordered review by the Precedential Opinion Panel (“POP”) of its decision denying institution in Hulu LLC v. Soundview Innovations LLC, IPR2018-01039, Paper No. 15 (December 3, 2018). Hulu requested rehearing of the decision arguing that the Board’s denial of institution conflicts with other Board…
Lupin recently announced approval in Japan to manufacture and sell an etanercept biosimilar, YLB113. YLB113 is approved to treat moderate to severe rheumatoid arthritis and juvenile idiopathic arthritis. YLB113 will be marketed in Japan by a joint venture between YL Biologics Limited and a Lupin subsidiary. This marks Lupin’s first…
According to a recent paper in The Lancet, a new phase 3 study shows that CT-P13, Celltrion and Pfizer’s infliximab biosimilar, is non-inferior to the reference biologic, REMICADE, for the treatment of Crohn’s disease. CT-P13 was approved by the European Commission under the trade name Remsima® in September 2013, and…
As we previously reported, in May 2017, the Competition and Markets Authority (CMA) in the United Kingdom reached a provisional conclusion that Merck Sharp & Dohme Limited (MSD) violated competition law through a discount pricing scheme for Remicade that was likely to restrict biosimilar competition. In March 2019, after considering…
We previously reported on the biosimilar trade secrets case, Genentech v. JHL. Genentech asserted claims including trade secret misappropriation under state and federal law, breach of contract, and breach of state and federal computer fraud and abuse acts. On March 20, the district court entered a case management order ,…
As we have reported, Samsung Bioepis is engaged in U.S. patent litigation and proceedings against Genentech in connection with Samsung Bioepis’s ONTRUZANT (trastuzumab-dttb) biosimilar product, which the U.S. FDA approved earlier this year. In addition to litigating a BPCIA case in federal district court that is currently scheduled for a…
As we previously reported, Pfizer recently filed a notice that it will not participate in the appeal of the final written decision of IPR2017-01168, which found all claims of U.S. Patent No. 8,821,873 unpatentable. The ‘873 patent is directed to a method of treating lymphoma with anti-CD20 antibodies. On March…