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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BPCIA
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In October, we reported on a growing number of IPR challenges to Genentech’s U.S. Patent No. 6,407,213 (“the ʼ213 patent”) to...
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On February 2, 2018, U.S. District Judge George H. Wu granted Genentech’s motion to dismiss a complaint brought by Amgen in the Central...
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U.S. Food & Drug Administration and European Medicines Agency approve first trastuzumab biosimilars U.S. Food & Drug...
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On January 11, 2018, Celltrion, Inc., Celltrion Healthcare, Co. Ltd. (collectively “Celltrion”), Teva Pharmaceuticals International...
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On December 14, 2017, the Federal Circuit issued an opinion in Amgen v. Sandoz, holding that the Biologics Price Competition and Innovation...
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The FDA has only approved eight biosimilar products to date. The second most recently approved biosimilar is Mvasi (bevacizumab-awwb),...
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Several of the Federal Circuit’s initial decisions involving the Biologics Price Competition and Innovation Act (the “BPCIA”) focused...
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European Medicines Agency newly approves two adalimumab biosimilars U.S. Food & Drug Administration approves first bevacizumab...
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