European Medicines Agency approves first two pegfilgrastim biosimilars and another adalimumab biosimilar Pfizer launches NivestymTM,...
BPCIA
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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
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By Seth Cockrum Comments are off
On August 10, 2018, AbbVie, Inc. and AbbVie Biotechnology Ltd. (collectively “AbbVie”) sued Sandoz Inc., Sandoz GMBH, and Sandoz...
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By Aydin Harston and Andrew Storaska Comments are off
FDA approves first Neulasta® (pegfilgrastim) and Procrit® (epoetin alfa) biosimilars and second Neupogen® (filgrastim biosimilar)...
Tagged with: BPCIA, EMA, FDA, Regulatory
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By Seth Cockrum Comments are off
As we previously reported here and here, Celltrion filed suit against Genentech seeking declaratory judgment that a host of patents...
Tagged with: BPCIA, Celltrion, Genentech, Herceptin®, News, Patent Dance, Rituxan®, Rituximab, trastuzumab
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By Nicole DeAbrantes Comments are off
On June 14, 2018, Senator Orrin Hatch of Utah, the co-author of the Hatch-Waxman Act, filed an amendment to the Hatch-Waxman Act in an...
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Litigation Spotlight Update: Epogen® Litigation Status in Face of Retacrit Regulatory Approval
By Spencer Johnson Comments are off
As we recently covered, May 15, 2018, saw the FDA granting approval to Hospira (now a Pfizer subsidiary) for its Retacrit injection, a...
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By Seth Cockrum Comments are off
As we previously reported here and here, Celltrion filed suit against Genentech seeking declaratory judgment that a number of patents...
Tagged with: BLA, BPCIA, Celltrion, District Court, Genentech, Herceptin®, News, Patent Dance, Rituxan®, Rituximab, trastuzumab
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By Aydin Harston and Andrew Storaska Comments are off
European Medicines Agency approves second trastuzumab and third insulin glargine biosimilars FDA has not approved any biosimilar...
Tagged with: BPCIA, EMA, FDA, Regulatory
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