---
schema_version: "secwatch.filing_event.v1"
accession: "0001104659-23-129338"
form_type: "8-K"
ticker: "CHRS"
cik: "0001512762"
company_name: "Coherus Oncology, Inc."
filed_at: "2023-12-27T23:59:59+00:00"
generated_at: "2026-06-07T06:53:44.670972+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.7
calibrated_materiality_score: 0.7
confidence: "high"
source: SEC EDGAR
---

# Coherus receives FDA approval for UDENYCA ONBODY on-body injector

## Summary
- FDA approved UDENYCA ONBODY on December 26, 2023, a pegfilgrastim biosimilar to reduce febrile neutropenia after chemotherapy.
- Product includes indicator light, auditive signal, and automatic needle retraction to confirm dose and reduce needlestick risk.
- Commercial launch planned for Q1 2024.
- Approval supported by pharmacokinetic/pharmacodynamic bioequivalence and adhesive performance data.

## SEC filing metadata
- accession: 0001104659-23-129338
- form_type: 8-K
- ticker: CHRS
- cik: 0001512762
- company_name: Coherus Oncology, Inc.
- filed_at: 2023-12-27T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.7
- calibrated_materiality_score: 0.7
- confidence: high
- sec_items: 8.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1512762/000110465923129338/0001104659-23-129338-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1512762/000110465923129338/tm2333730d1_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001104659-23-129338
- JSON: https://secwatch.observer/filing/0001104659-23-129338.json
- Plain text: https://secwatch.observer/filing/0001104659-23-129338.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.