---
schema_version: "secwatch.filing_event.v1"
accession: "0001104659-25-052994"
form_type: "8-K"
ticker: "OGN"
cik: "0001821825"
company_name: "Organon & Co."
filed_at: "2025-05-27T23:59:59+00:00"
generated_at: "2026-05-20T11:19:00.684278+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.65
calibrated_materiality_score: 0.65
confidence: "high"
source: SEC EDGAR
---

# FDA designates Organon's HADLIMA as interchangeable biosimilar to Humira across all presentations

## Summary
- FDA granted interchangeability for HADLIMA high- and low-concentration (40 mg/0.4 mL, 40 mg/0.8 mL) autoinjectors and high-concentration prefilled syringe.
- HADLIMA is now interchangeable with all formulations of Humira, including low-concentration prefilled syringe and single-dose vial (granted June 2024).
- Designation based on PK, efficacy, safety, and immunogenicity study of SB5 vs Humira in moderate to severe plaque psoriasis patients.
- Interchangeability allows pharmacists to substitute HADLIMA for Humira without consulting prescriber, subject to state pharmacy laws.
- Average patient out-of-pocket cost for Humira was more than four times that of HADLIMA, per Organon data.

## SEC filing metadata
- accession: 0001104659-25-052994
- form_type: 8-K
- ticker: OGN
- cik: 0001821825
- company_name: Organon & Co.
- filed_at: 2025-05-27T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.65
- calibrated_materiality_score: 0.65
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1821825/000110465925052994/0001104659-25-052994-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1821825/000110465925052994/tm2516205d1_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001104659-25-052994
- JSON: https://secwatch.observer/filing/0001104659-25-052994.json
- Plain text: https://secwatch.observer/filing/0001104659-25-052994.txt

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