Sandoz announced last week that the FDA issued a complete response letter for its proposed biosimilar to rituximab. In the announcement,...
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Last week, on April 18, 2018, Judge Stark in the District of Delaware entered the Final Judgment and Order dismissing the patent...
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Fujifilm Kyowa Kirin Biologics Co., Ltd. (“Fujifilm”) recently announced that it will partner with Mylan N.V. (“Mylan”) to...
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On the same day that the PTAB instituted review of an AbbVie Biotechnology Ltd. (“AbbVie”) patent covering a method of using adalimumab...
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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...
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We previously reported that on January 11, 2018, Celltrion, Inc., Celltrion Healthcare, Co. Ltd. (collectively “Celltrion”), Teva...
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On January 11, 2018, Celltrion, Inc., Celltrion Healthcare, Co. Ltd. (collectively “Celltrion”), Teva Pharmaceuticals International...
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Sandoz announced that its biosimilar application for Neulasta® (pegfilgrastim) has been accepted for regulatory review by the European...
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As previously reported, earlier this year Celltrion, Inc. (“Celltrion”) filed petitions seeking inter partes review (“IPR”) of...
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As we previously reported, Celltrion filed three petitions seeking inter partes review (“IPR”) of two patents related to Genentech and...