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This article provides an update on our prior analysis of the infliximab litigation involving Janssen Biotech, Inc. (“Janssen”),...
By Daniel McCallum Comments are off
This article provides an update on our prior analysis of the infliximab litigation involving Janssen Biotech, Inc. (“Janssen”),...
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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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