UDENYCA On Body Receives FDA Clearance: Groundbreaking On-Body Injector Transforms Cancer Treatment Administration

Coherus BioSciences announced on December 26, 2023, that the U.S. Food and Drug Administration has granted approval for UDENYCA ONBODY™, an innovative on-body injector presentation designed specifically for pegfilgrastim-cbqv administration. This latest delivery innovation marks a significant advancement for patients undergoing chemotherapy who require pegfilgrastim to combat febrile neutropenia.

What Sets This On-Body Injector Apart

The UDENYCA on body device represents a ground-up engineering achievement rather than an adaptation of existing technology. Unlike modified versions of devices from other medical applications, this system was built from the foundation specifically for pegfilgrastim delivery. The five-minute injection window dramatically simplifies the patient experience compared to traditional delivery methods.

A defining safety feature is the automatic needle retraction mechanism, which engages immediately after dose delivery. This proprietary design substantially reduces needlestick injury risks—a critical concern for patients managing their own medication administration. The device incorporates visual and auditory confirmation signals, allowing patients to verify successful dose delivery with absolute certainty.

The adhesive formulation underwent extensive testing for durability and skin compatibility, with manufacturers engineering it to maintain secure placement throughout the medication delivery window while minimizing removal-related discomfort.

Clinical and Analytical Foundation

FDA approval was supported by comprehensive data packages encompassing pharmacokinetic and pharmacodynamic bioequivalence studies. Adhesive performance metrics and tolerability assessments across diverse patient populations validated the device’s reliability. This evidence base demonstrates that the on-body injector delivers pegfilgrastim-cbqv with consistent efficacy comparable to existing UDENYCA presentations.

Expanding Treatment Flexibility

UDENYCA is now available through three distinct administration pathways: traditional prefilled syringes, autoinjector pens, and the new on-body injector format. This portfolio approach addresses variable patient preferences and clinical scenarios. Since UDENYCA’s market introduction in 2019, the biosimilar has been administered to over 300,000 patients, establishing a substantial clinical track record.

The commercial rollout of UDENYCA on body is targeted for Q1 2024, enabling broader adoption among oncology practices and individual patients.

Indication and Safety Considerations

UDENYCA is indicated to decrease infection incidence (manifested as febrile neutropenia) in non-myeloid malignancy patients receiving myelosuppressive chemotherapy. It also increases survival in patients acutely exposed to myelosuppressive radiation doses under Hematopoietic Subsyndrome of Acute Radiation Syndrome protocols.

Important Safety Alerts:

Patients with documented serious allergic reactions to pegfilgrastim or filgrastim products should not receive UDENYCA. The device employs acrylic adhesive; patients with acrylic sensitivities require alternative formulations.

Rare but serious events warrant clinical monitoring: splenic rupture (evaluate left upper quadrant pain), acute respiratory distress syndrome (discontinue if suspected), severe allergic reactions including anaphylaxis (permanently discontinue if occurs), and sickle cell crisis in susceptible populations (discontinue immediately).

Ongoing vigilance for glomerulonephritis, elevated leukocyte counts (WBC ≥100 x 10⁹/L documented), thrombocytopenia, capillary leak syndrome, and aortitis is essential. Potential device failures resulting in missed or partial doses require immediate healthcare provider notification to assess replacement dose necessity.

Myelodysplastic syndrome and acute myeloid leukemia associations have been reported when pegfilgrastim is combined with chemotherapy or radiotherapy in breast and lung cancer populations; appropriate monitoring protocols should be implemented.

Most frequently reported adverse effects are bone pain and extremity pain, occurring in ≥5% of patients above placebo comparisons.

Corporate Context

Coherus BioSciences operates as a commercial-stage biopharmaceutical enterprise concentrating on cancer immunotherapy research, development, and commercialization. Beyond UDENYCA, the company markets CIMERLI® (ranibizumab-eqrn), a Lucentis biosimilar, and YUSIMRY™ (adalimumab-aqvh), a Humira biosimilar. The immuno-oncology pipeline includes Casdozokitug (anti-IL-27 antibody in Phase 1/2 and Phase 2 trials), CHS-114 (ADCC-enhanced anti-CCR8 in Phase 1/2), CHS-006 (TIGIT-targeted antibody in Phase 1/2), and CHS-1000 (preclinical ILT4 pathway targeting program). LOQTORZI™ (toripalimab-tpzi), a next-generation PD-1 inhibitor, was planned for U.S. launch in January 2024.

For adverse event reporting: Contact Coherus at 1-800-4-UDENYCA (1-800-483-3692) or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.