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AbbVie Files BPCIA Suit Against Boehringer Ingelheim Over Humira (Adalimumab)
  • Rothwell, Figg, Ernst & Manbeck, PC
  • USA
  • August 16 2017

Recently, AbbVie, Inc. and AbbVie Biotechnology, LTD (collectively “AbbVie” or “Plaintiffs”) filed a Complaint in the United States District Court


Samsung Bioepis and Merck Launch Renflexis in the U.S.
  • Rothwell, Figg, Ernst & Manbeck, PC
  • USA
  • August 10 2017

On July 24, 2017, Samsung Bioepis and Merck & Co., Inc. announced the launch of Renflexis (infliximab-abda) in the United States. According to


FDA Grants Tentative Approval for Merck’s Insulin Glargine
  • Rothwell, Figg, Ernst & Manbeck, PC
  • USA
  • July 25 2017

Merck & Co., Inc. (“Merck”) announced last week that the FDA has granted tentative approval for its insulin glargine injection LusdunaTM NexvueTM, a


FDA Advisory Committee Recommends Approval of CAR-T Cell Therapy and Two New Biosimilars
  • Rothwell, Figg, Ernst & Manbeck, PC
  • USA
  • July 19 2017

The FDA’s Oncologic Drug Advisory Committee (“ODAC”) held a public meeting on Wednesday, July 12, 2017, to consider Novartis’ biologic license


Celltrion’s Application for Rituxan (rituximab) Biosimilar Accepted by FDA
  • Rothwell, Figg, Ernst & Manbeck, PC
  • USA
  • July 3 2017

Celltrion announced last week that its Biologics License Application (“BLA”) for CT-P10, a biosimilar to Biogen and Genentech’s Rituxan (rituximab)


FDA Advisory Committee Meeting Announced for Amgen’s and Allergan’s Proposed Biosimilar to Avastin (Bevacizumab)
  • Rothwell, Figg, Ernst & Manbeck, PC
  • USA
  • June 9 2017

The FDA announced yesterday that the Oncologic Drug Advisory Committee (“ODAC”) has scheduled a public meeting to review ABP 215, Amgen’s proposed


FDA Advisory Committee Recommends Approval of Pfizer’s Proposed Biosimilar to Amgen’s EpogenProcrit (epoetin alfa)
  • Rothwell, Figg, Ernst & Manbeck, PC
  • USA
  • May 31 2017

Pfizer announced last week that the FDA’s Oncologic Drug Advisory Committee (ODAC) recommended its proposed biosimilar to Amgen’s EpogenProcrit for


Janssen Files BPCIA Patent Infringement Suit Against Samsung Bioepis’s Renflexis (infliximab-abda)
  • Rothwell, Figg, Ernst & Manbeck, PC
  • USA
  • May 30 2017

Earlier this month, Janssen Biotech, Inc., a subsidiary of Johnson and Johnson, (“Janssen” or “Plaintiff”) filed a Complaint in the United States


Celltrion Challenges Another Herceptin Patent With Two New IPR Petitions
  • Rothwell, Figg, Ernst & Manbeck, PC
  • USA
  • May 18 2017

Last week, Celltrion, Inc. (“Celltrion”) filed two new petitions for inter partes review (“IPR”) of U.S. Patent No. 6,407,213 (“the ’213 patent”)


C. Nichole Gifford
  • Rothwell, Figg, Ernst & Manbeck, PC