On April 25, 2019, the U.S. Food and Drug Administration (“FDA”) approved new biosimilar product EticovoTM (etanercept-ykro) by...
Benjamin R. Holt
To learn about Mr. Holt's practice, please visit http://www.rfem.com/professionals/bholt.
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By Benjamin R. Holt
Over four years ago, in October 2014, Amgen initiated a patent infringement suit against Sanofi and Regeneron regarding biologics for...
Tagged with: Amgen, FDA, Federal Circuit, Praluent®, Regeneron, Repatha®, Sanofi, Supreme Court
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By C. Nichole Gifford and Benjamin R. Holt
RFEM’s Biosimilars IPR Dashboard provides current information on IPR proceedings related to proposed biosimilar...
Tagged with: abatacept, adalimumab, Avastin®, bevacizumab, Enbrel®, etanercept, Featured, Herceptin®, Humira®, IPR, Legal, Natalizumab, Neulasta®, News, Orencia®, pegfilgrastim, PTAB, Rituxan®, Rituximab, trastuzumab, Tysabri®, USPTO
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By Benjamin R. Holt
The August 2018 Update to the PTAB Trial Practice Guide added guidance regarding the Patent Trial and Appeal Board’s (“the Board”)...
Tagged with: Boehringer Ingelheim, Intervet International B.V., IPR, Merial, News, PTAB
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By Benjamin R. Holt
The FDA has only approved eight biosimilar products to date. The second most recently approved biosimilar is Mvasi (bevacizumab-awwb),...