Tagged as: Coherus

Coherus Settles with AbbVie, and Sues Amgen, Over Adalimumab Biosimilars (Updated)

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…

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Coherus Biosciences Launches UDENYCA (pegfilgrastim-cbqv), and Secures $75 Million Credit Financing to Accelerate Manufacture and Sale

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…

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Coherus Enters into Prime Vendor Agreement with Apexus that Includes Udenyca™

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…

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Coherus Files Responsive Appellate Brief in Amgen v. Coherus (pegfilgrastim)

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…

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FDA Approves Second Pegfilgrastim Biosimilar, a First for Coherus

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…

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FDA accepts Coherus’s resubmitted pegfilgrastim biosimilar application

As we reported earlier this month, Coherus BioSciences recently resubmitted its application for CHS-1701, a proposed biosimilar to Neulasta® (pegfilgrastim), in response to a Complete Response Letter that it received from the FDA last June. Yesterday, Coherus announced that the FDA has accepted its pegfilgrastim resubmission and that the FDA considered…

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Coherus Files Two More Petitions for IPR of Abbvie's '619 Humira Patent

Coherus Biosciences has filed two petitions for inter partes review of Abbvie’s U.S. Patent 9,085,619.  (IPR2017-01008 and IPR2017-01009).  Coherus recently filed four other petitions for inter partes review of the ‘619 patent, as we’ve reported.  Those cases are pending an institution decision. According to the petitions, the ‘619 patent is drawn…

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