This article provides an update on our prior analysis of the infliximab litigation involving Janssen Biotech, Inc. (“Janssen”),...
Celltrion
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By C. Nichole Gifford Comments are off
On May 25, 2017, Pfizer, Inc. (“Pfizer”) filed two new petitions for inter partes review (“IPR”) of U.S. Patent No. 6,407,213...
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By C. Nichole Gifford Comments are off
Last week, Celltrion, Inc. (“Celltrion”) filed two new petitions for inter partes review (“IPR”) of U.S. Patent No. 6,407,213...
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By C. Nichole Gifford Comments are off
Over the last two weeks, Pfizer, Inc. (“Pfizer”) has filed petitions for inter partes review (“IPR”) of three additional patents...
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By C. Nichole Gifford Comments are off
Celltrion announced last week that it has submitted an application for approval of Herzuma, its proposed trastuzumab biosimilar (CT-P6), in...
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By C. Nichole Gifford Comments are off
FDA approved Samsung Bioepis’s Renflexis® (SB2, infliximab-abda) on Friday, April 21, 2017. Renflexis® is the fifth biosimilar...
Tagged with: Biogen, Celltrion, FDA, Inflectra®, Infliximab, Janssen, News, Regulatory, Remicade®, Renflexis®, Samsung Bioepsis
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By Daniel McCallum Comments are off
Editors’ Note: Although the BPCIA was enacted seven years ago, to date, only four biosimilar products have been approved by the FDA, and...
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By C. Nichole Gifford Comments are off
On March 31, 2017, Celltrion, Inc. (“Celltrion”) filed three new petition for inter partes review (“IPR”) of two additional patents...
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By C. Nichole Gifford Comments are off
Pfizer, Inc. (“Pfizer”) filed a new petition with the Patent Trial and Appeal Board (“PTAB”) on March 24, 2017, for inter partes...
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