On November 8, 2018, on its quarterly earnings call for Q3 2018 (transcript available here), Coherus BioSciences provided updates regarding its commercial launch plans for its recently approved Udenyca™ (pegfilgrastim-cbqv) biosimilar product. President, CEO and Chairman Denny Lefler told financial analysts on the call that Udenyca™ will be available for…
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…
On November 1, 2018, Genentech and its co-plaintiffs dismissed the lawsuits they brought against Celltrion and Teva under the BPCIA in the District of New Jersey, in which the plaintiffs alleged that Celltrion’s filing of an aBLA relating to Truxima®, Celltrion’s proposed biosimilar to Rituxan® (rituximab), infringed certain patents. The…
Today, AbbVie and Momenta announced that they have entered into an agreement under which AbbVie has granted Momenta a global, royalty-bearing non-exclusive license to AbbVie’s intellectual property relating to Humira® (adalimumab). According to the press releases, the deal authorizes Momenta to launch its adalimumab biosimilar, M923, in the United States…
Below are some recent updates regarding biosimilar pipelines from around the globe. On November 2, 2018, Sandoz announced that it has decided “not [to] pursue its submission for biosimilar rituximab in the US at this time … follow[ing] a request by the US Food and Drug Administration (FDA) for additional…
On October 23, 2018, we previously reported that the Federal Circuit ordered Momenta to show cause as to why Momenta’s appeal of a PTAB decision upholding the patentability of BMS’s U.S. Patent No. 8,476,239, relating to BMS’s ORENCIA® (abatacept) product, should not be dismissed as moot. Pursuant to Fed. R. App. P….
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…
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…
Last week, NeuClone Ltd. announced it commenced its Phase I clinical trial for its biosimilar Herceptin® (trastuzumab). According to NeuClone, the Phase I trial is a single-dose, randomized, three-arm double blind study of over 100 healthy volunteers, conducted under the Australian Clinical Trial Notification (CTN) scheme. According to NeuClone, “[t]his…