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RFEM’s Biosimilars IPR Dashboard provides current information on IPR proceedings related to proposed biosimilar...
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 C. Nichole Gifford
Recently, AbbVie, Inc. and AbbVie Biotechnology, LTD (collectively “AbbVie” or “Plaintiffs”) filed a Complaint in the United States...
Tagged with: AbbVie, adalimumab, Boehringer Ingelheim, BPCIA, District Court, Humira®, Legal, Litigation, Patent Dance
By C. Nichole Gifford
Amgen and Allergan recently announced that they submitted a Biologics License Application (“BLA”) for ABP 980, a proposed biosimilar to...
Tagged with: Allergan, Amgen, Biocon, Celltrion, FDA, Genentech, Herceptin®, Hospira, Mylan, News, Pfizer, Regulatory, Teva, trastuzumab
By C. Nichole Gifford
Sandoz, Inc. (“Sandoz”) entered into the battlefield over patents related to AbbVie’s Humira® (adalimumab). On July 20, 2017,...
Tagged with: adalimumab, Humira®, Invalidity, IPR, News, PTAB, Sandoz, USPTO, Validity
By C. Nichole Gifford
On July 24, 2017, Samsung Bioepis and Merck & Co., Inc. announced the launch of Renflexis® (infliximab-abda) in the United States. ...
Tagged with: Infliximab, Janssen, Merck, News, Remicade®, Renflexis®, Samsung Bioepsis
By C. Nichole Gifford
Merck & Co., Inc. (“Merck”) announced last week that the FDA has granted tentative approval for its insulin glargine injection...
Tagged with: Diabetes, Follow-on biologic, Insulin glargine, Lantus®, Legal, LUSDUNA™ Nexvue™, Merck, News, Sanofi
By C. Nichole Gifford
Novartis’ First CAR-T Cell Therapy Tisagenlecleucel (CTL019) The FDA’s Oncologic Drug Advisory Committee (“ODAC”) held a public...
Tagged with: Allergan, Amgen, Avastin®, bevacizumab, Biocon, CAR-T, FDA, Genentech, Herceptin®, Mylan, News, Novartis, Regulatory, Roche, Tisagenlecleucel, trastuzumab
By C. Nichole Gifford
Boehringer Ingelheim International GMBH and Boehringer Ingelheim Pharmaceuticals, Inc. (“Boehringer Ingelheim”) have prevailed in two...
Tagged with: AbbVie, adalimumab, Amgen, Boehinger Ingleheim, Coherus, Humira®, Legal, News, PTAB
By C. Nichole Gifford
On June 30, 2017, Pfizer, Inc. (“Pfizer”) filed two new petitions for inter partes review (“IPR”) of U.S. Patent No. 8,591,897...
By C. Nichole Gifford
Celltrion announced last week that its Biologics License Application (“BLA”) for CT-P10, a biosimilar to Biogen and Genentech’s...