As we previously reported, Celltrion filed three petitions seeking inter partes review (“IPR”) of two patents related to Genentech and Biogen’s Rituxan® (rituximab). Celltrion filed two petitions seeking review of U.S. Patent No. 7,682,612 (“the ʼ612 patent”) and one petition seeking review of U.S. Patent No. 8,206,711 (“the ʼ711 patent”). The PTAB has now reached
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
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 22, 2017, the Committee for Medicinal Products for Human Use (“CHMP”) of the European Medicine’s Agency (“EMA”) recommended Samsung Bioepis’ Imraldi® (SB-5, adalimumab), a biosimilar to AbbVie’s Humira®, for approval. The CHMP’s recommendation will be referred to the European Commission for final marketing authorization.
Adalimumab is a TNF (tumor necrosis factor) inhibitor
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
FDA approved Samsung Bioepis’s Renflexis® (SB2, infliximab-abda) on Friday, April 21, 2017. Renflexis® is the fifth biosimilar approved by the FDA and the second infliximab biosimilar to Janssen’s Remicade®. Infliximab is an Anti-Tumor Necrosis Factor (Anti-TNF) monoclonal antibody approved in the U.S. for treating rheumatoid arthritis, ulcerative colitis, Crohn’s disease, ankylosing spondylitis, psoriatic arthritis, and
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
Samsung Bioepsis UK Limited (“Samsung”), Biogen Idec Limited (“Biogen”), and Fujifilm Kyowa Kirin Biologic Company Limited (“Fujifilm Biologics”) have prevailed against two of AbbVie’s patents for Humira® in the UK.
On March 3, 2017, Justice Henry Carr of the UK High Court of Justice issued a decision declaring that administration of 40mg of adalimumab once