Inter partes review (“IPR”) is one of several post-grant procedures created by the Leahy Smith America Invents Act (“AIA”). An...
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Celltrion, Inc. (“Celltrion”) filed a petition with the Patent Trial and Appeal Board (“PTAB”) on August 15, 2016 for inter partes...
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Celltrion’s Truxima (CT-P10, rituximab), a biosimilar to Rituxan® received approval from the European Commission on February 22, 2017. ...
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Celltrion, Inc. (“Celltrion”) filed a new petition with the Patent Trial and Appeal Board (“PTAB”) on February 21, 2017 for inter...
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On February 15, 2017, Genentech filed litigation accusing Amgen of violating the Biologics Price Competition and Innovation Act...
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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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Dr. Leah Christl, the FDA’s Associate Director for Therapeutic Biologics, Office of New Drugs Therapeutic Biologics and Biosimilars Team...
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Coherus Biosciences, Inc. (“Coherus”) has filed four petitions with the Patent Trial and Appeal Board (“PTAB”) for inter partes...
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Hospira, Inc. (“Hospira”) filed two additional new petitions with the Patent Trial and Appeal Board (“PTAB”) on January 30, 2017...
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The Supreme Court has agreed to hear its first biosimilar case interpreting two provisions of the Biologics Price Competition and...