On January 18, 2019, in Amgen v. Sanofi, the ongoing litigation concerning Sanofi and Regeneron’s Praluent® (alirocumab) product, Judge Andrews of the District of Delaware denied Sanofi’s motion for summary judgment that the asserted genus claims directed to monoclonal antibodies that inhibit PCSK9 (such as Amgen’s Repatha® and Sanofi/Regeneron’s Praluent® products)…
Earlier this month, it was reported by the Regulatory Affairs Professional Society (RAPs) that Pfizer has terminated five biosimilar projects in preclinical development. According RAPs, Pfizer’s Director of Global Media Relations, Thomas Biegi, said that resources from these programs would be reallocated “to late stage programs across Pfizer’s other key…
Coherus announced today that it has executed settlement agreements with AbbVie that grant Coherus global, non-exclusive, royalty-bearing license rights under AbbVie’s intellectual property to commercialize CHS-1420, Coherus’ proposed adalimumab biosimilar. According to the press release, the “global settlements resolve all pending disputes between the parties related to Coherus’ adalimumab biosimilar,” with Coherus’s…
In March this year, Amgen sued Adello Biologics under the BPCIA in the District of New Jersey for infringement of seventeen patents, based on Adello’s submission of an aBLA for a biosimilar of Neupogen® (filgrastim). In October, Amgen filed an amended complaint, reducing the number of asserted patents to four,…
As we previously reported, Amgen is appealing the District Court’s decision to dismiss, with prejudice, Amgen’s patent infringement complaint against Coherus regarding its (recently approved) biosimilar of Neulasta® (pegfilgrastim). Amgen filed its opening brief on August 20, challenging the district court’s dismissal of the suit. On October 31, 2018, Coherus filed…
Early last month, we reported that in the Amgen v. Hospira BPCIA litigation concerning Hospira’s Retacrit™ (epoetin alfa) biosimilar, Hospira had filed an appeal to the Federal Circuit from the Delaware district court’s final judgment of infringement and validity of one of the patents-in-suit, U.S. Patent No. 5,856,298, and the…
Amgen, Sandoz, Samsung and Mylan all launched adalimumab biosimilars in Europe this past October. On October 16, 2018, Amgen has announced that its adalimumab biosimilar AMGEVITA launched in European markets. This is Amgen’s first “inflammation” biosimilar to launch in Europe, and its second biosimilar to launch in Europe overall. According to…
Amgen has announced that its adalimumab biosimilar AMGEVITA launched yesterday in European markets. This is Amgen’s first “inflammation” biosimilar to launch in Europe, and its second biosimilar to launch in Europe overall. According to Amgen, two Phase 3 studies confirmed that AMGEVITA showed biosimilarity to adalimumab, showing no clinically meaningful…
As we have previously reported, a jury in September 2017 issued a $70,000,000 verdict against Hospira based on its drug substance manufacturing activity in 2013-2015 in connection with its biosimilar of Amgen’s Epogen® (epoetin alfa). The parties then engaged in post-trial motion practice, seeking to overturn various portions of the…
Amgen filed a complaint against Apotex today in the Middle District of Florida, alleging infringement of U.S. Patent No. 9,856,287 based on Apotex’s aBLAs for filgrastim and pegfilgrastim biosimilars. The ’287 patent issued on January 2, 2018 and is directed to methods of protein refolding in non-mammalian expression systems. According to…