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
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
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.”
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
On June 30, 2017, Pfizer, Inc. (“Pfizer”) filed two new petitions for inter partes review (“IPR”) of U.S. Patent No. 8,591,897 (“the ’897 patent”) related to Genentech’s Herceptin® (trastuzumab). Pfizer has a trastuzumab biosimilar in phase III development, but it has not yet announced the filing of an application for that product with the
Celltrion announced last week that its Biologics License Application (“BLA”) for CT-P10, a biosimilar to Biogen and Genentech’s Rituxan® (rituximab), has been accepted for review by the Food and Drug Administration (“FDA”). The FDA is expected to act on the application in the first quarter of 2018.
Rituximab is an anti-CD20 monoclonal antibody approved for
On June 19, 2017, the European Commission (EC) approved Sandoz’s Rixathon® (rituximab), a biosimilar to Roche/Genentech’s Rituxan®/Mabthera®. The approval follows the positive recommendation by the Committee for Medicinal Products for Human Use (“CHMP”) issued two months ago.
Rituximab is an anti-CD20 monoclonal antibody approved for the treatment of non-Hodgkin’s lymphoma (follicular lymphoma and diffuse large
The FDA announced yesterday that the Oncologic Drug Advisory Committee (“ODAC”) has scheduled a public meeting to review ABP 215, Amgen’s proposed biosimilar to Genentech’s Avastin (bevacizumab), on July 13, 2017. According to the announcement, the proposed indications and uses for ABP 215 include:
On May 25, 2017, Pfizer, Inc. (“Pfizer”) filed two new petitions for inter partes review (“IPR”) of U.S. Patent No. 6,407,213 (“the ’213 patent”). The ‘213 patent, entitled “Method for Making Humanized Antibodies,” issued on June 18, 2002. Although the IPR petitions do not identify a particular biologic, Genentech has publicly stated that the technology
Last week, Celltrion, Inc. (“Celltrion”) filed two new petitions for inter partes review (“IPR”) of U.S. Patent No. 6,407,213 (“the ’213 patent”) related to Genentech’s Herceptin® (trastuzumab). Celltrion has announced that it plans to submit an application for a trastuzumab biosimilar product to the FDA this year (possibly as early as next month), as reported