We previously reported that Apotex filed a Citizen’s Petition requesting that FDA require biosimilar applicants to conduct comparative clinical efficacy studies in at least one intended patient population, rather than conducting such studies only in healthy subjects. Apotex noted in its petition that Coherus has filed an aBLA for a Neulasta…
As we previously reported, the FDA announced that the Oncologic Drugs Advisory Committee (ODAC) will hold a public meeting on May 25, 2017 to discuss Hospira’s application for a proposed biosimilar of Amgen’s Epogen®/Procrit® (epoetin alfa). The FDA has now posted meetings materials associated with the May 25th meeting. The…
Pfizer, Inc. has filed two petitions for IPR of Chugai Pharmaceutical’s patents: IPR2017-01357 on U.S. Patent 7,332,289 and IPR2017-01358 on U.S. Patent 7,927,815. According to the petitions, both patents are directed to methods for purifying antibodies. The petitions do not identify a particular product that may use the patented methods….
A Stipulation and Scheduling Order for Trial (Order) entered on May 19, 2017 in the Amgen v. Sandoz litigation rescheduled trial for March 26, 2018 (from December 18, 2017), and pushed back other pre-trial deadlines. According to the Order, the parties had previously proposed separate modified schedules, but at a…
On May 17, 2017, Janssen filed a complaint under the BPCIA in the District of New Jersey against Samsung Bioepis Co., Ltd. regarding Renflexis® (infliximab-abda), Samsung Bioepis’s recently approved biosimilar of Remicade®. The complaint alleges infringement of three patents: U.S. Patent No. 7,598,083, 6,900,056 and 6,773,600. According to the complaint, the…
The Association for Accessible Medicines (AAM) and the Biosimilars Council, a division of AAM, released comments today on FDA’s Draft Guidance on Considerations in Demonstrating Interchangeability With a Reference Product (“Draft Guidance”), which was made publicly available in January 2017. AAM, previously known as the Generic Pharmaceutical Association, represents “the manufacturers…
GE Healthcare announced today that Dr. Reddy’s will install GE Healthcare’s FlexFactory in Dr. Reddy’s facility in Hyderabad, India. According to the press release, “FlexFactory will help Dr. Reddy’s increase its capacity to meet both the expected growth of its currently marketed biosimilars as well as support the launch of…
The PTAB has issued a Final Written Decision in IPR2016-00172, filed by Coherus, finding Abbvie’s U.S. Patent 8,889,135 unpatentable as obvious over the prior art. The ‘135 patent is directed to methods of treating rheumatoid arthritis with a human anti-tumor necrosis factor α (TNF) antibody. Patent Owner tried to defend the…
Researchers in Denmark recently published a report from an observational study of 802 Danish patients who switched from Remicade to the biosimilar infliximab product Remsima for the treatment of rheumatoid arthritis, psoriatic arthritis, and axial spondyloarthritis. In May 2015, Denmark implemented a national guideline mandating non-medical switching of all patients…
Last week, Hospira filed a motion for summary judgment of non-infringement asserting that “all of Hospira’s accused erythropoietin drug substance batches are protected by the safe harbor provisions of 35 U.S.C. § 271(e)(1) and thus do not infringe U.S. Patent Nos. 5,756,349 and 5,856,298.” Hospira further stated that it does not infringe…