
On February 21, 2019, Sandoz Inc. (“Sandoz”) filed suit against Amgen Inc. and Amgen Manufacturing Limited (collectively “Amgen”)...
By Seth Cockrum Comments are off
On February 21, 2019, Sandoz Inc. (“Sandoz”) filed suit against Amgen Inc. and Amgen Manufacturing Limited (collectively “Amgen”)...
Tagged with: Amgen, District Court, filgrastim, News, pegfilgrastim, Sandoz
ShareEmail, Linked In, Twitter, Facebook, Google Plus
By C. Nichole Gifford and Benjamin R. Holt Comments are off
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
ShareEmail, Linked In, Twitter, Facebook, Google Plus
By Caitlin M. Wilmot Comments are off
Earlier this month, Amgen initiated suit against Apotex in the Middle District of Florida, alleging infringement of U.S. Patent No....
Tagged with: Amgen, Apotex, BPCIA, filgrastim, Litigation, Neulasta®, Neupogen®, pegfilgrastim
ShareEmail, Linked In, Twitter, Facebook, Google Plus
By Andrew Storaska Comments are off
Earlier this month, the U.S. FDA announced approval of Mylan’s Fulphila biosimilar to Neulasta® (pegfilgrastim). Neulasta® was...
ShareEmail, Linked In, Twitter, Facebook, Google Plus
By Seth Cockrum Comments are off
Last week, on April 18, 2018, Judge Stark in the District of Delaware entered the Final Judgment and Order dismissing the patent...
ShareEmail, Linked In, Twitter, Facebook, Google Plus
By Aydin Harston Comments are off
Biologic drugs are large molecules, such as therapeutic proteins, DNA vaccines, monoclonal antibodies, and fusion proteins, that are...
Tagged with: Amgen, Apotex, BLA, FDA, Federal Circuit, filgrastim, IPR, Neulasta®, Neupogen®, pegfilgrastim, PTAB
ShareEmail, Linked In, Twitter, Facebook, Google Plus
By Seth Cockrum Comments are off
Sandoz announced that its biosimilar application for Neulasta® (pegfilgrastim) has been accepted for regulatory review by the European...
Tagged with: EMA, Neulasta®, pegfilgrastim, Sandoz, Zioxtenzo
ShareEmail, Linked In, Twitter, Facebook, Google Plus
By Andrew Storaska Comments are off
Biologic drugs are quickly reshaping the pharmaceutical landscape as they dominate the drug market in annual sales revenue. Abbvie’s...
Tagged with: adalimumab, Avastin®, bevacizumab, Enbrel®, etanercept, European Commission, Herceptin®, Humira®, Infliximab, Neulasta®, pegfilgrastim, Remicade®, Rituxan®, Rituximab, trastuzumab
ShareEmail, Linked In, Twitter, Facebook, Google Plus
Posted in:
By Rachel M. Echols Comments are off
Introduction and Background The Apotex filgrastim/pegfilgrastim biosimilar litigation was the first biosimilar litigation where the...
Tagged with: Amgen, Amgen v. Apotex, Apotex, BPCIA, District Court, Featured, Federal Circuit, filgrastim, Legal, Litigation, Litigation Spotlight, Neulasta®, Neupogen®, Notice, Notice Requirement, Patent Dance, pegfilgrastim
ShareEmail, Linked In, Twitter, Facebook, Google Plus