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
Over the last two weeks, Pfizer, Inc. (“Pfizer”) has filed petitions for inter partes review (“IPR”) of three additional patents related to Biogen and Genentech’s Rituxan® (rituximab) at the Patent Trial and Appeal Board (“PTAB”). The proceedings are: IPR2017-01166, filed on April 21, 2017, regarding U.S. Patent No. 8,329,172 (“the ’172 patent”); IPR2017-1167, filed on
Celltrion announced last week that it has submitted an application for approval of Herzuma, its proposed trastuzumab biosimilar (CT-P6), in Japan. Trastuzumab is a monoclonal antibody indicated for the treatment of patients with metastactic breast cancer whose tumors overexpress the HER2 protein and who have received one or more chemotherapy regimens. Celltrion’s Herzuma (trastuzumab) is
Pfizer, Inc. (“Pfizer”) filed a new petition with the Patent Trial and Appeal Board (“PTAB”) on March 24, 2017, for inter partes review (“IPR”) of U.S. Patent No. 7,820,161 (“the ’161 patent”) related to Biogen’s and Genentech’s Rituxan® (rituximab). The challenged claims of the ’161 patent are directed to a method for treating rheumatoid arthritis
On March 2, 2017, the PTAB issued a decision denying Celltrion, Inc.’s (“Celltrion”) request for inter partes review (“IPR”) of claims 1-14 of U.S. Patent No. 7,976,838 related to Genentech’s Rituxan® (rituximab). This denial comes less than a week after the PTAB instituted IPR of U.S. Patent No. 7,820,161, related to the same product,
Celltrion, Inc. (“Celltrion”) filed a petition with the Patent Trial and Appeal Board (“PTAB”) on August 15, 2016 for inter partes review (“IPR”) of U.S. Patent No. 7,820,161 (“the ’161 patent”) related to Genentech’s Rituxan® (rituximab). On February 24, 2017, the PTAB issued a decision instituting review of claims 1–3, 5–7, and 9–11 of
Celltrion’s Truxima (CT-P10, rituximab), a biosimilar to Rituxan® received approval from the European Commission on February 22, 2017. Rituximab is an anti-CD20 monoclonal antibody approved for the treatment of non-Hodgkin’s lymphoma, chronic lyphocytic leukemia, rheumatoid arthritis, granulomatosis with polyangitis, and microscopic polyangitis. The EMA’s Committee for Medicinal Products for Human Use (CHMP) recommended Truximab for