
On April 25, 2019, the U.S. Food and Drug Administration (“FDA”) approved new biosimilar product EticovoTM (etanercept-ykro) by...
To learn about Mr. Holt's practice, please visit http://www.rfem.com/professionals/bholt.
By Benjamin R. Holt
On April 25, 2019, the U.S. Food and Drug Administration (“FDA”) approved new biosimilar product EticovoTM (etanercept-ykro) by...
Tagged with: aBLA, Amgen, BPCIA, Enbrel®, etanercept, Eticovo, FDA, Featured, Patent Dance, Regulatory, Samsung Bioepis, Sandoz
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
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
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
By Benjamin R. Holt
The FDA has only approved eight biosimilar products to date. The second most recently approved biosimilar is Mvasi (bevacizumab-awwb),...