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…
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…
Last June, we reported that Coherus BioSciences had received a Complete Response Letter (CRL) from the FDA for CHS-1701, a proposed biosimilar to Neulasta® (pegfilgrastim). Later, in August, we reported that Coherus had anticipated resubmitting its BLA in response to the CRL. Today, Coherus announced that it has resubmitted its BLA…
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…
Today, the PTAB instituted IPR proceedings on claims 1-5 of U.S. Patent No. 8,889,135, drawn to a method of treating a rheumatoid arthritis patient with a TNFα-inhibitor. Humira®, marketed by Abbvie, is allegedly covered by the claims of the ’135 patent. The IPR petition was filed by Coherus Biosciences, Inc….