Sandoz announced last week that the FDA issued a complete response letter for its proposed biosimilar to rituximab. In the announcement, Sandoz stated that it “stands behind the robust body of evidence included in the regulatory submission and is currently evaluating the content of the letter.” Sandoz further indicated that although disappointed, it “remains committed
On the same day that the PTAB instituted review of an AbbVie Biotechnology Ltd. (“AbbVie”) patent covering a method of using adalimumab to treat psoriatic arthritis, it also instituted review of a second AbbVie patent directed to the use of adalimumab to treat chronic plaque psoriasis. More specifically, and once again at the urging of
At the urging of Sandoz Inc. (“Sandoz”), the PTAB instituted review of claims 1, 2, and 5-7 of U.S. Patent No. 9,067,992 (“the ʼ992 patent”) on April 3, 2018. The ʼ992 patent is entitled “Use of TNFα Inhibitor for Treatment of Psoriatic Arthritis,” and is assigned to AbbVie Biotechnology Ltd. (“AbbVie”). The claims of the
Sandoz’s request for inter partes review (“IPR”) of U.S. Patent Numbers 9,512,216 (“the ’216 patent”) and 8,802,100 (“the ’100 patent”) was denied by the Patent Trial and Appeal Board (“the Board”) on the grounds that Sandoz did not show that the patents were likely unpatentable. The decisions not to institute an IPR of either patent
On December 14, 2017, the Federal Circuit issued an opinion in Amgen v. Sandoz,[i] holding that the Biologics Price Competition and Innovation Act of 2009 (“BPCIA,” the “Act”) preempts state law, and thus state laws cannot be used to enforce participation in the BPCIA’s patent dispute resolution procedures and disclosure process. In light of
On November 6, 2017, Sandoz, Inc. filed its eighth inter partes review (“IPR”) against AbbVie Biotechnology Ltd. (“AbbVie”), challenging yet another patent from the Humira® patent portfolio. Humira®, used for the treatment of autoimmune diseases such as rheumatoid arthritis and Crohn’s disease, continues to be the number one selling drug in the world.[i] With
Sandoz announced that its biosimilar application for Neulasta® (pegfilgrastim) has been accepted for regulatory review by the European Medicines Agency (“EMA”). According to Sandoz, “[t]he comprehensive data package, submitted as part of the Marketing Authorization Application, includes analytical, preclinical and clinical data and strongly demonstrates that the biosimilar pegfilgrastim matches the reference medicine in terms
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
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