Drugs / CT-P47
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | US (FDA) | — | rheumatoid arthritis | 2024-01-28 | “Celltrion USA today announced the submission of Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for CT-P47” celltrion.com ↗ “Celltrion USA completes submission of Biologics License Application for CT-P47, a biosimilar candidate of ACTEMRA® (tocilizumab)” celltrion.com ↗ |
| Filed | EU (EMA) | — | rheumatoid arthritis | — | “CT-P47 was filed for regulatory approval with the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) in January and February 2024 respectively.” celltrion.com ↗ |
Trials 3
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial · 1 met primary | ||||||
| Phase 1 | NCT05188378 | Dec 2021 → Oct 2022 | — | Celltrion | Unknown | Met primary |
| Phase 32 trials · 1 met primary | ||||||
| Phase 3 | NCT05725434 | Feb → Apr 2023 | rheumatoid arthritis | Celltrion | Unknown | No outcome recorded |
| Phase 3 | NCT05489224 | Sep 2022 → Jun 2023 | rheumatoid arthritis | Celltrion | Completed | Met primary |
| Comparator or background therapy1 trial | ||||||
| Phase 1 | NCT05617183 Comparator | Nov 2022 → Apr 2023 | — | Celltrion | Unknown | No outcome recorded |
News releases announcing trial results or a regulatory action · 7
| Date | Issuer | Release |
|---|---|---|
| 2025-08-07 | Celltrion | Regulatory FDA approves expanded indication for AVTOZMA® (tocilizumab-anoh) intravenous (IV) formulation in cytokine release syndrome (CRS) celltrion.com ↗
Approval of AVTOZMA® (tocilizumab-anoh) intravenous infusion expands label to include treatment of adults and pediatric patients aged 2 years and older with cytokine release syndrome (CRS) |
| 2025-02-24 | Celltrion | Regulatory Celltrion Receives EC Approval for Avtozma® (CT-P47), a Biosimilar to RoActemra® (tocilizumab) celltrion.com ↗
Celltrion today announced that the European Commission (EC) has granted marketing authorization for Avtozma® (CT-P47), a biosimilar referencing RoActemra® (tocilizumab). |
| 2025-01-31 | Celltrion | Regulatory U.S. FDA approves Celltrion's AVTOZMA® (tocilizumab-anoh), a biosimilar to ACTEMRA® celltrion.com ↗
Celltrion today announced that the U.S. Food and Drug Administration (FDA) has approved AVTOZMA® (CT-P47, tocilizumab-anoh) in both an intravenous (IV) and subcutaneous (SC) formulation as a biosimilar to ACTEMRA®. |
| 2024-12-16 | Celltrion | Regulatory Celltrion Receives Positive CHMP Opinion for Three Biosimilars in the European Union celltrion.com ↗
Avtozma, a biosimilar referencing RoActemra® (tocilizumab), has been recommended for all indications of its reference product, including moderate to severely active rheumatoid arthritis (RA), active systemic juvenile idiopathic arthritis (sJIA), juvenile idiopathic polyarthritis (pJIA) and giant cell arteritis (GCA). |
| 2024-11-19 | Celltrion | Results Celltrion presents additional data from phase III randomized controlled trials to further support biosimilarity for CT-41 (biosimilar candidate of denosumab) and CT-P47 (biosimilar candidate of tocilizumab) at ACR Convergence 2024 celltrion.com ↗ |
| 2024-06-14 | Celltrion | Results Celltrion showcases promising results in phase III study for CT-P47, a biosimilar candidate of RoActemra® (tocilizumab) in patients with rheumatoid arthritis (RA) at EULAR 2024 celltrion.com ↗
Data from the Phase III comparative clinical trial demonstrated that the investigational biosimilar candidate, CT-P47, has an equivalent efficacy, and comparable safety and immunogenicity profile to the reference tocilizumab product. |
| 2024-01-29 | Celltrion | Regulatory Celltrion USA completes submission of Biologics License Application for CT-P47, a biosimilar candidate of ACTEMRA® (tocilizumab) celltrion.com ↗
Celltrion USA today announced the submission of Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for CT-P47, a biosimilar candidate of the reference product ACTEMRA® (tocilizumab)[1]. |
All press releases naming this drug 7 releases
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 4 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | CT-P47 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05617183 ↗ |
| Modality | Monoclonal antibody | “CT-P47, containing the active ingredient tocilizumab, is a recombinant humanized monoclonal antibody” NCT05489224 ↗ |
| Route | Intravenous | “by intravenous (IV) infusion” NCT05489224 ↗ |