
European Medicines Agency approves first two pegfilgrastim biosimilars and another adalimumab biosimilar Pfizer launches NivestymTM,...
By Aydin Harston Comments are off
European Medicines Agency approves first two pegfilgrastim biosimilars and another adalimumab biosimilar Pfizer launches NivestymTM,...
Tagged with: BPCIA, EMA, FDA, Featured, Regulatory
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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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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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