Earlier this month, the U.S. FDA announced approval of Mylan’s Fulphila biosimilar to Neulasta® (pegfilgrastim). Neulasta® was...
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Biocon
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Last week, Mylan N.V. and Biocon Ltd. announced that their jointly-developed insulin glargine biosimilar, Semglee™, received marketing...
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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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Amgen and Allergan recently announced that they submitted a Biologics License Application (“BLA”) for ABP 980, a proposed biosimilar to...
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Novartis’ First CAR-T Cell Therapy Tisagenlecleucel (CTL019) The FDA’s Oncologic Drug Advisory Committee (“ODAC”) held a public...
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Hospira, Inc. (“Hospira”) filed a petition with the Patent Trial and Appeal Board (“PTAB”) on September 16, 2016 for inter partes...
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On March 10, 2017, the PTAB published a decision terminating the proceedings in IPR2016-1693 and IPR2016-1694 because the parties have...
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The FDA has accepted for review an application submitted by Mylan N.V. (“Mylan”) and Biocon Ltd. (“Biocon”) under the 351(k)...
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