Drugs / CT-P17
CT-P17
English name adalimumab
also known as
adalimumab
Monoclonal antibody targets TNF via inhibition
Trials 3
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial · 1 met primary | ||||||
| Phase 1 | NCT03970824 | May → Nov 2019 | — | Celltrion | Completed | Met primary |
| Phase 32 trials · 2 met primary | ||||||
| Phase 3 | NCT05495568 | Nov 2022 → Aug 2023 | psoriasis | Celltrion | Completed | Met primary |
| Phase 3 | NCT03789292 | Nov 2018 → Oct 2019 | rheumatoid arthritis | Celltrion | Completed | Met primary |
| Comparator or background therapy1 trial | ||||||
| Phase 1 | NCT04295356 Comparator | Jun → Nov 2019 | — | Celltrion | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 8
| Date | Issuer | Release |
|---|---|---|
| 2025-10-17 | Celltrion | Regulatory FDA approves expanded pediatric indications for YUFLYMA® (adalimumab-aaty) and unbranded adalimumab-aaty in the United States celltrion.com ↗
YUFLYMA® (adalimumab-aaty), and its unbranded version, are now approved for two additional pediatric indications – adolescent hidradenitis suppurativa (HS) and pediatric uveitis (UV), in the U.S. |
| 2025-05-23 | Celltrion | Regulatory Celltrion's YUFLYMA® (adalimumab-aaty) receives FDA interchangeability designation for all its approved dosage forms and strengths celltrion.com ↗
Celltrion, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted an expanded interchangeable designation for YUFLYMA® (adalimumab-aaty), now including prefilled syringe (40mg) and autoinjectors (40mg and 80mg) presentations. |
| 2025-04-15 | Celltrion | Regulatory U.S. FDA grants interchangeable designation to YUFLYMA® (adalimumab-aaty), Celltrion's biosimilar to Humira® (adalimumab) celltrion.com ↗
Celltrion, Inc. today announced that the U.S. Food and Drug Administration (FDA) has designated YUFLYMA® (adalimumab-aaty), as an interchangeable biosimilar to Humira® (adalimumab). |
| 2023-05-24 | Celltrion | Regulatory Celltrion USA Announces U.S. FDA Approval of Yuflyma® (adalimumab-aaty), a High-Concentration and Citrate-Free Formulation of Humira® (adalimumab) Biosimilar celltrion.com ↗
Celltrion USA today announced that the U.S. Food and Drug Administration (FDA) has approved Yuflyma® (adalimumab-aaty), a high-concentration (100mg/mL) and citrate-free formulation of Humira® (adalimumab) biosimilar. |
| 2021-06-02 | Celltrion | Results Celltrion Healthcare Presents Positive One-Year Data for the First High-Concentration, Low-Volume and Citrate-Free Biosimilar Adalimumab YuflymaTM celltrion.com ↗
Celltrion Healthcare today presented positive results from the Phase III CT-P17 3.1 trial comparing the efficacy and safety of biosimilar adalimumab, Yuflyma™, with reference adalimumab in patients with active rheumatoid arthritis (RA) at the Annual European Congress of Rheumatology 2021 (EULAR Virtual Congress 2021). |
| 2021-02-15 | Celltrion | Regulatory Celltrion Healthcare receives European Commission (EC) approval for the first high concentration, low-volume and citrate-free biosimilar adalimumab celltrion.com ↗
Celltrion Healthcare today announced that on February 11th, the European Commission (EC) has granted marketing authorisation for Yuflyma™ (CT-P17), an adalimumab biosimilar, across all thirteen intended indications for the treatment of multiple chronic inflammatory diseases. |
| 2020-12-11 | Celltrion | Regulatory Celltrion Healthcare receives EU CHMP positive opinion for biosimilar adalimumab, CT-P17 celltrion.com ↗
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion of CT-P17 (adalimumab biosimilar) for the treatment of multiple chronic inflammatory diseases |
| 2020-11-03 | Celltrion | Results Celltrion Healthcare Presents Positive Top-Line Efficacy and Safety Results for CT-P17 in the Treatment of Rheumatoid Arthritis celltrion.com ↗
Results demonstrated CT-P17 has equivalent efficacy to reference adalimumab - the ACR20 response rate at week 24 was 82.7% (268/324) for both CT-P17 and reference adalimumab. |
All press releases naming this drug 17 releases
Evidence & citations 6 cited values
Every value below carries the sentence it was read from. 6 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | CT-P17 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05495568 ↗ |
| Known as | adalimumab | “Randomised, phase I pharmacokinetic study of adalimumab biosimilar CT-P17 (40 mg/0.4 mL) by autoinjector and prefilled syringe in healthy subjects.” PMID 33822406 ↗ May 20211“CT-P17 is a recombinant human monoclonal antibody containing the active ingredient adalimumab (human TNF-α blocker).” NCT05495568 ↗ |
| Action | Inhibit | “human TNF-α blocker” NCT05495568 ↗ |
| Modality | Monoclonal antibody | “CT-P17, containing the active ingredient adalimumab, is a recombinant humanized monoclonal antibody” NCT03789292 ↗ |
| Route | Subcutaneous | “receive a single 40 mg (100 mg/ml) subcutaneous injection of CT-P17, US-adalimumab, or EU-adalimumab” PMID 33503313 ↗ Mar 2021 |
| Target | TNF | “human TNF-α blocker” NCT05495568 ↗ |