Coherus BioSciences, Inc. announced the launch of UDENYCA ONBODY, the company's on-body injector (OBI) presentation of UDENYCA (pegfilgrastim-cbqv), is successfully underway, with a broad distribution of accounts nationwide ordering this innovative device, and patients now accessing its benefits. UDENYCA is a pegfilgrastim biosimilar administered the day after chemotherapy to decrease the incidence of infection as manifested by febrile neutropenia. UDENYCA ONBODY was designed with patients in mind; key features include a five-minute injection time, an indicator, status light and auditory signal that help patients confirm the dose has been administered and a strong and well-tolerated adhesive.

After the dose is administered, the needle automatically retracts, which reduces the risk of needlestick injury. UDENYCA ONBODY is available through existing full-line and specialty distributors. Billing under the medical benefit for UDENYCA ONBODY is streamlined because it has the same permanent, product-specific Q-Code as the prefilled syringe, Q5111, and a unique NDC number of 70114-0130-01.

UDENYCA Solutions? offers healthcare professionals comprehensive practice and patient support that includes extensive patient assistance and office support to ensure successful access, billing, and reimbursement. More details regarding UDENYCA ONBODY, including video instructions for ONBODY preparation and application.

UDENYCA is the only pegfilgrastim brand approved in the United States available in three administration options?prefilled syringe (PFS), autoinjector (AI) and on-body injector?providing patients and healthcare providers with choice, control, and convenience. Since its launch in 2019, over 300,000 patients have been treated with UDENYCA. INDICATION 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.

Increase survival in patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Subsyndrome of Acute Radiation Syndrome). 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. Allergies to Acrylics: The on-body injector (OBI) for UDENYCA uses acrylic adhesive. For patients who have reactions to acrylic adhesives, use of this product may result in a significant reaction.

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: hrombocytopenia 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.

Potential Device failures: Missed or partial doses have been reported for products administered via on-body injectors due to the device not performing as intended. In the event of a missed or partial dose, patients may be at increased risk of events such as neutropenia, febrile neutropenia and/or infection than if the dose had been correctly delivered. Instruct patients using the OBI to notify their healthcare professional immediately to determine the need for a replacement dose of UDENYCA if they suspect that the device may not have performed as intended.

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.