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Coherus Announces Positive Results of UDENYCA® On-Body Injector Clinical Trial
- UDENYCA® On-Body Injector (OBI) Achieved Both Pharmacokinetic and Pharmacodynamic Bioequivalence in Randomized Clinical Trial - Coherus plans to seek U.S.
About this update from Coherus Oncology, Inc.
[{"type":"text","content":"- UDENYCA® On-Body Injector (OBI) Achieved Both Pharmacokinetic and Pharmacodynamic Bioequivalence in Randomized Clinical Trial - Coherus plans to seek U.S. marketing authorization for the UDENYCA® OBI in 2022 REDWOOD CITY, Calif., Oct. 05, 2021 (GLOBE NEWSWIRE) -- Coherus BioSciences, Inc. (“the Company”; Nasdaq: CHRS) today announced positive results from a randomized, open-label, crossover study assessing the pharmacokinetic (PK) and pharmacodynamic (PD) bioequivalence of UDENYCA® (pegfilgrastim-cbqv) administered via a proprietary on-body injector (OBI) device compared to the currently marketed UDENYCA® pre-filled syringe (PFS). The study met all PK bioequivalence primary endpoints as well as the key secondary pharmacodynamic endpoint of ANC (absolute neutrophil count). No new safety signals were observed. The study enrolled 189 subjects randomized 1:1 to receive one of two treatment sequences of UDENYCA®: OBI followed by PFS, or the reverse, with a treatment interval of 6 to 8 weeks. Coherus plans a 2022 submission to the United States Food and Drug Administration (FDA) of a prior approval supplement to seek marketing authorization for the UDENYCA® OBI and anticipates a standard 10-month review period. Coherus expects commercial launch of the UDENYCA® OBI directly post approval. “UDENYCA® quickly became the top-selling pre-filled syringe pegfilgrastim in the U.S. within months of launch in 2019, establishing Coherus as a trusted partner to oncologists and demonstrating the power of biosimilar competition to expand patient access to an important cancer medicine,” said Denny Lanfear, CEO of Coherus. “With our OBI program progress, we are excited by the potential to offer to providers and patients a new on-body injector presentation of UDENYCA®, if approved, and to compete directly with Neulasta® Onpro®, which retains more than 50% share of the overall pegfilgrastim market.” An FDA-approved UDENYCA® OBI would offer providers a highly desired alternative to the originator’s on-body pegfilgrastim delivery system and eliminate the need for patients to return to a hospital or other clinical setting the day after chemotherapy to receive UDENYCA®. About UDENYCA®UDENYCA® is the #1 prescribed pegfilgrastim pre-filled syringe in the United States.UDENYCA® is a leukocyte growth factor indicated to decrease the incidence of infection, as...