On November 8, 2016, Amgen submitted a brief in opposition to Apotex’s petition for certiorari challenging the Federal Circuit’s application of its holding in Amgen v. Sandoz that subsection (l)(8)(A) of the BPCIA allows an aBLA applicant to provide notice of commercial marketing only after it receives approval, as well…
While Donald Trump’s victory has made world headlines, what may be less well known to our readers is that the election also gave Trump’s Republican Party majority control of both the House and the Senate. For the first time in many years, Republicans will control both the White House and…
On November 2, the Biosimilars Forum released the results of a survey in an article titled “Awareness, Knowledge, and Perceptions of Biosimilars Among Specialty Physicians,” published in Advances in Therapy. According to the abstract of the article, the survey was conducted from November, 2015, through January, 2016, and sought to assess…
The election last night of Donald Trump as the next President of the United States may have far-reaching consequences on numerous legal and policy issues, including immigration, international trade, and health care. Although we are not aware of President-elect Trump ever directly mentioning biosimilars on the campaign trail, it is…
On November 8, 2016, Mylan and Biocon submitted an aBLA for MYL-1401O, a proposed biosimilar to Genentech’s Herceptin® (trastuzumab). According to the Mylan press release, this submission is Mylan’s first for a biosimilar in the United States, and may lead to the first approved trastuzumab biosimilar in the United States. Mylan…
The PTAB has denied institution of inter partes review of Abbvie’s U.S. Patent No. 9,114,166, finding that Petitioner Coherus had not established a reasonable likelihood that it would prevail in showing the unpatentability of the challenged claims. The ‘166 patent is drawn to pharmaceutical formulations comprising an anti-TNFα antibody, and…
Amgen recently announced that the FDA has approved its supplemental Biologics License Application for the expanded use of Enbrel® (etanercept) to treat pediatric patients (ages 4-17) with chronic moderate-to-severe plaque psoriasis. According to Amgen, Enbrel® is now “the first and only systemic therapy” for this indication, the approval of which was “based…
The appeal from Janssen Biotech, Inc. v. Celltrion Healthcare Co. (D. Mass. No. 15-10698) has been docketed at the Federal Circuit with the number 17-1120. Janssen’s opening brief is due on December 27, 2016. We have posted extensively on the district court case, most recently here, and will continue to post on…
The FDA has accepted Genentech’s BLA for a subcutaneous formulation of rituximab. The drug is indicated to treat non-Hodgkin’s lymphoma, chronic lymphocytic leukemia, moderate to severe rheumatoid arthritis, Wegener’s granulomatosis and microscopic polyangiitis. According to Genentech, its formulation uses a recombinant human hyaluronidase enzyme from Halozyme, approved and marketed under…
As we previously reported, Amgen filed an appeal brief challenging the district court’s resolution of its discovery dispute with Hospira and addressing the issue of whether the Federal Circuit had jurisdiction to hear the appeal. On October 25, 2016, Hospira filed a responsive appeal brief asserting that (1) the Court does not…