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

On March 31, 2017, Celltrion, Inc. (“Celltrion”) filed three new petition for inter partes review (“IPR”) of two additional patents related to Genentech and Biogen’s Rituxan® (rituximab).  Two of the petitions challenge claims of U.S. Patent No. 7,682,612 (“the ’612 patent”) and the other seeks review of all nine claims of U.S. Patent No.8,206,711 (“the

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

Celltrion, Inc. (“Celltrion”) filed three new petitions with the Patent Trial and Appeal Board (“PTAB”) on March 15, 2017 for inter partes review (“IPR”) of Biogen’s U.S. Patent Nos. 8,329,172 (“the ’172 patent”), 8,557,244 (“the ’244 patent”), and 9,296,821 (“the ’821 patent”) related to rituximab.

Rituximab is an anti-CD20 monoclonal antibody approved for the treatment

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