Regeneron’s EYLEA (aflibercept) was approved by the U.S. FDA on November 18, 2011 and is indicated for the treatment of patients with Neovascular (Wet) Age-related Macular Degeneration (AMD), Macular Edema following Retinal Vein Occlusion (RVO), Diabetic Macular Edema (DME), and Diabetic Retinopathy (DR). As previously reported, Momenta in collaboration with Mylan began…
Mylan announced on its most recent quarterly earnings call that it expects to launch its rituximab and etanercept biosimilars in Europe later this year. In discussing Mylan’s biosimilars pipeline, Rajiv Malik, Mylan’s President, told market analysts, “we also have for Europe rituximab and Enbrel biosimilars, which will be most likely…
As we previously reported, earlier this year Coherus filed a complaint against Amgen in the District of Delaware alleging infringement of patents claiming “stable aqueous pharmaceutical compositions” comprising adalimumab and other components. Coherus alleged that “Amgen is actively offering for sale and selling Amgevita™ [Amgen’s tradename for its adalimumab biosimilar…
On May 2, 2019 Coherus BioSciences, Inc. (“Coherus”) announced that it has settled the trade secret action brought by Amgen Inc. (“Amgen”) relating to Amgen’s Neulasta® and Coherus’ Udenyca® products. In March 2017, Amgen filed a complaint alleging a “massive conspiracy” by disloyal former Amgen employees in a “concerted effort…
As we previously reported, on January 24, 2019, Coherus filed a complaint against Amgen in the District of Delaware alleging that Amgen’s adalimumab product for sale in Europe, Amgevita™, infringes three Coherus formulation patents related to adalimumab because Amgen allegedly manufactures its European product in the United States. As we also reported, Coherus amended its…
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…
Coherus Biosciences announced today that it has entered into a $75 million senior secured credit facility agreement with Healthcare Royalty Partners. According to the press release, the funds will be used to “accelerate and enhance the manufacture and sale of UDENYCA (pegfilgrastim-cbqv).” The press release also confirms that UDENYCA launched…
Last week, Coherus BioSciences, Inc. announced that it had entered into a 340B prime vendor program contract agreement with Apexus, LLC. This agreement includes Udenyca™, which, as we reported last month, is the second biosimilar of Neulasta® (pegfilgrastim) to have received FDA approval. According to the press release, Apexus’s president, Chris Hatwig, stated…
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…
Today, Coherus BioSciences announced that the U.S. FDA has approved Udenyca™ (pegfilgrastim-cbqv), its biosimilar of Amgen’s Neulasta®, for patients with cancer receiving myelosuppressive chemotherapy. Udenyca™, which received marketing authorization in Europe in September, is Coherus’ first biosimilar to obtain approval in the United States. Udenyca™ is the fourteenth biosimilar to…