RFEM’s Biosimilars IPR Dashboard provides current information on IPR proceedings related to proposed biosimilar...
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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
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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
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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
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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
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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
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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
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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
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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...
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By C. Nichole Gifford
Celltrion announced last week that its Biologics License Application (“BLA”) for CT-P10, a biosimilar to Biogen and Genentech’s...