Last week, Pfizer, Inc. (“Pfizer”) filed two petitions for inter partes review (“IPR”) of two patents related to Genentech and Biogen’s Rituxan® (rituximab). One petition challenges all but two claims of U.S. Patent No. 7,682,612 (“the ʼ612 patent”), and has been assigned IPR2017-02126. The other petition seeks review of all nine claims of U.S. Patent
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AbbVie and Amgen Settle Humira Patent Litigation
On September 28, 2017, AbbVie and Amgen announced a global settlement of their patent dispute surrounding Amgen’s proposed biosimilar to HUMIRA. The terms of the agreement remain confidential between the parties, but according to the announcement, AbbVie will grant Amgen a non-exclusive license for the use and sale of Amgen’s biosimilar (AMGEVITA) to HUMIRA. Amgen…
Pfizer Files Another IPR Against Genentech’s ʼ441 Patent
On October 3, 2017, Pfizer, Inc. (“Pfizer”) filed a petition for inter partes review (“IPR”) against U.S. Patent No. 7,846,441 (“the ʼ441 patent”), assigned to Genentech, Inc. (“Genentech”), entitled “Treatment with anti-ErbB2 antibodies.” The ʼ441 patent is related to Genentech’s Herceptin® (trastuzumab) product. Last November, Pfizer announced positive results in a pivotal safety and efficacy…
Two New Applications for Trastuzumab (Herceptin®) Biosimilars Pending at FDA
Amgen and Allergan recently announced that they submitted a Biologics License Application (“BLA”) for ABP 980, a proposed biosimilar to Genentech’s Herceptin® (trastuzumab), to the Food and Drug Administration (“FDA”). According to the press release, Amgen and Allegan have “formed a collaboration to develop and commercialize, on a worldwide basis, four oncology antibody biosimilar medicines.”…
Sandoz Enters IPR Battlefield on Humira® Patents
Sandoz, Inc. (“Sandoz”) entered into the battlefield over patents related to AbbVie’s Humira® (adalimumab). On July 20, 2017, Sandoz filed petitions with the Patent Trial and Appeal Board (“PTAB”) for inter partes review (“IPR”) of two patents assigned to AbbVie, U.S. Patent No. 8,802,100 (“the ’100 patent”) entitled “Formulation of Human Antibodies for Treating TNF-Alpha…
Samsung Bioepis and Merck Launch Renflexis® in the U.S.
On July 24, 2017, Samsung Bioepis and Merck & Co., Inc. announced the launch of Renflexis® (infliximab-abda) in the United States. According to Merck’s press release, Renflexis® “will be introduced in the U.S. [at] . . . a 35 percent discount to the current list price” of the reference product. Renflexis® is the second FDA-approved…
FDA Reauthorization Bill is Enacted–Changes Biosimilar User Fees and Review Model
The U.S. Senate passed S.934 – FDA Reauthorization Act of 2017 on Thursday, August 3, 2017, by a 94-1 vote after having been passed by the House last month, as reported here. The President immediately signed it into law.
As we previously reported, the Biosimilar User Fee Act “BsUFA II” portion of the FDA…
FDA Grants Tentative Approval for Merck’s Insulin Glargine
Merck & Co., Inc. (“Merck”) announced last week that the FDA has granted tentative approval for its insulin glargine injection LusdunaTM NexvueTM, a follow-on biologic to Sanofi’s Lantus®. Because Merck’s application for insulin glargine was filed using the abbreviated 505(b)(2) regulatory pathway provided by the Hatch-Waxman Amendments (not a section (k) application…
FDA Advisory Committee Recommends Approval of CAR-T Cell Therapy and Two New Biosimilars
Novartis’ First CAR-T Cell Therapy Tisagenlecleucel (CTL019)
The FDA’s Oncologic Drug Advisory Committee (“ODAC”) held a public meeting on Wednesday, July 12, 2017, to consider Novartis’ biologic license application (BLA 125646) for tisagenlecleucel (CTL019), an investigational chimeric antigen receptor T cell (“CAR-T”) therapy. Novartis is seeking approval of CTL019 for the treatment of patients from…
Boehringer Ingelheim Prevails in IPR Against AbbVie’s ’135 Humira Patent
Boehringer Ingelheim International GMBH and Boehringer Ingelheim Pharmaceuticals, Inc. (“Boehringer Ingelheim”) have prevailed in two inter parts review trials against one of AbbVie’s patents related to Humira®. In two final written decisions issued, the Patent Trial and Appeal Board (the “PTAB” or “Board”) found all claims of U.S. Patent No. 8,889,135 (the ’135 patent”) invalid.…