Search Results for: "amgen v coherus"

BREAKING NEWS: Federal Circuit Affirms Coherus Victory Over Amgen in Pegfilgrastim Patent Dispute

As we previously reported, last year Amgen appealed a Delaware district court’s decision dismissing Amgen’s patent infringement complaint under the BPCIA against Coherus on the ground that Coherus’s biosimilar of NEULASTA (pegfilgrastim) could not be found to infringe Amgen’s patent under the doctrine of equivalents (Amgen’s only asserted basis for…

Read More

Biosimilar-Related Patent Litigation Updates

Here are some recent developments in U.S. legal proceedings relating to biosimilars: On December 10, 2018, in the Southern District of Florida, Apotex filed a motion to dismiss the patent infringement complaint that Amgen filed this past August alleging patent infringement based on Apotex’s filing of aBLAs for pegfilgrastim and filgrastim biosimilar…

Read More

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…

Read More

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…

Read More

Biologic and Biosimilar Litigation Updates

Below we provide updates in three pending litigations. First, in an update on the Amgen v. Coherus appeal regarding Coherus’s biosimilar application for pegfilgrastim, Amgen filed its opening brief on August 20. Amgen’s statement of the issues reads: 1. Whether the district court erred in dismissing Amgen’s Complaint, with prejudice, based…

Read More

BPCIA Litigation Roundup (Q2 2018)

Below is our second quarter update on the U.S. patent litigations concerning proposed or approved biosimilar products. For additional details, please consult our previous quarterly updates (Q3 2016, Q4 2016, Q1 2017, Q2 2017, Q3 2017, Q4 2017, Q1 2018). Please also refer to our BPCIA Patent Litigation and Federal…

Read More