On October 5, 2021 Coherus BioSciences, Inc. ("the Company"; Nasdaq: CHRS) reported 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)(Press release, Coherus Biosciences, OCT 5, 2021, View Source [SID1234590818]). 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.
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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 manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia.
Limitations of Use: UDENYCA is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation.
Contraindications: Patients with a history of serious allergic reactions to pegfilgrastim products or filgrastim products. Reactions have included anaphylaxis.
Warnings and Precautions:
Fatal splenic rupture: Evaluate patients who report left upper abdominal or shoulder pain for an enlarged spleen or splenic rupture.
Acute respiratory distress syndrome (ARDS):
Evaluate patients who develop fever, lung infiltrates, or respiratory distress. Discontinue UDENYCA in patients with ARDS.
Serious allergic reactions, including anaphylaxis:
The majority of reported events occurred upon initial exposure. Allergic reactions, including anaphylaxis, can recur within days after the discontinuation of initial anti-allergic treatment. Permanently discontinue UDENYCA in patients with serious allergic reactions.
Sickle cell crises: Severe and sometimes fatal crises have occurred. Discontinue UDENYCA if sickle cell crisis occurs.
Glomerulonephritis: The diagnoses were based upon azotemia, hematuria (microscopic and macroscopic), proteinuria, and renal biopsy. Generally, events resolved after dose reduction or discontinuation. Evaluate and consider dose-reduction or interruption of UDENYCA if causality is likely.
Leukocytosis: White blood cell (WBC) counts of 100 x 109/L or greater have been observed in patients receiving pegfilgrastim products. Monitoring of complete blood count (CBC) during UDENYCA therapy is recommended.
Thrombocytopenia: Thrombocytopenia has been reported in patients receiving pegfilgrastim. Monitor platelet counts.
Capillary Leak Syndrome: Has been reported after G-CSF administration, including pegfilgrastim products, and is characterized by hypotension, hypoalbuminemia, edema, and hemoconcentration. Episodes vary in frequency, severity and may be life-threatening if treatment is delayed. If symptoms develop, closely monitor and give standard symptomatic treatment, which may include a need for intensive care.
Potential for Tumor Growth Stimulatory Effects on Malignant Cells: The possibility that pegfilgrastim products act as a growth factor for any tumor type, including myeloid malignancies and myelodysplasia, diseases for which pegfilgrastim products are not approved, cannot be excluded.
Myelodysplastic Syndrome (MDS) and Acute Myeloid Leukemia (AML) in Patients with Breast and Lung Cancer: MDS and AML have been associated with the use of pegfilgrastim in conjunction with chemotherapy and/or radiotherapy in patients with breast and lung cancer. Monitor patients for sign and symptoms of MDS/AML in these settings.
Aortitis: Has been reported in patients receiving pegfilgrastim products, occurring as early as the first week after start of therapy. Manifestations may include generalized signs and symptoms such as fever, abdominal pain, malaise, back pain, and increased inflammatory markers (e.g., c-reactive protein and white blood cell count). Consider aortitis when signs and symptoms develop without known etiology. Discontinue UDENYCA if aortitis is suspected.
Nuclear Imaging: Increased hematopoietic activity of the bone marrow in response to growth factor therapy has been associated with transient positive bone imaging changes. Consider when interpreting bone imaging results.
Adverse Reactions: Most common adverse reactions (≥ 5% difference in incidence compared to placebo) are bone pain and pain in extremity.