As we previously reported, the United States District Court for the District of Massachusetts denied Celltrion’s motion to dismiss for lack of standing in the Janssen v. Celltrion case. On November 14, 2017, Celltrion filed a motion to certify the court’s order for interlocutory review by the Federal Circuit. In…
On November 14, 2017, Theradiag, a French company specializing in in vitro diagnostics, announced that it had entered into a partnership agreement with Biogen to provide LISA TRACKER kits for monitoring Flixabi®, Biogen’s infliximab biosimilar that is marketed in Europe. Theradiag’s LISA TRACKER kits allow clinicians to monitor trough plasma…
We post frequently about citizen petitions here on the blog. Since the 1970s, the citizen petition process has allowed individual persons or organizations to request that FDA take or not take certain regulatory actions, such as not approving pending new drug applications. In recent years, the citizen petition process has come…
We previously reported on Genentech’s complaint in the District of Delaware alleging that Amgen’s MVASI™ (bevacizumab-awwb) infringes over twenty Genentech patents and Amgen’s motion to transfer that complaint to the Central District of California. Today Amgen filed its reply (redacted) in support of transfer. In its reply, Amgen addresses Genentech’s…
Genentech filed a complaint last Friday in the District of Delaware against Pfizer for infringement of 40 patents under the BPCIA regarding PF-05280014, Pfizer’s biosimilar of Herceptin® (trastuzumab). According to the complaint, the FDA accepted Pfizer’s aBLA for review on August 21, 2017. Genentech’s complaint acknowledges that the parties had started, but not completed, the information exchanges of the…
We previously reported on Amgen’s complaint in the Central District of California seeking a declaratory judgment that 27 Genentech patents are not infringed by Genentech’s bevacizumab biosimilar (Mvasi®). On November 15, 2017, Genentech moved to dismiss the Amgen DJ action. Genentech argues that the court lacks jurisdiction over Amgen’s DJ action…
Samsung Bioepis announced today that the European Commission (EC) has granted marketing authorization for Ontruzant®, a biosimilar for Herceptin® (trastuzumab), across all 28 European Union member states and the European Economic Area member states of Norway, Iceland and Liechtenstein. According to the press release, Ontruzuant® is approved for the treatment of…
Here are some updates since our last IPR update: HUMIRA On November 6, 2017, Sandoz filed an IPR Petition challenging AbbVie’s U.S. Patent No. 9,187,559 (IPR2018-00156). The ‘559 patent is directed to a method for treating idiopathic inflammatory bowel disease. RITUXAN On November 6, 2017, the Board denied institution of an IPR on Pfizer’s…
On November 14, 2017, Sandoz announced data from four clinical trials comparing its proposed adalimumab and rituximab biosimilars to their reference drugs, Humira® and Rituxan®. We previously reported that the Sandoz adalimumab biosimilar is currently under EMA review. As we reported here, the Sandoz rituximab biosimilar has been approved by the European Commission…
Last week, FDA Commissioner Scott Gottlieb announced new draft guidance on risk evaluation and mitigation strategies (REMS) programs. The draft guidance provides for a single shared Drug Master File submission for all manufacturers of the same drug, which eliminates duplicative paperwork. This draft guidance is part of the FDA’s new two-pronged…