Drugs / BAT2206
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | EU (EMA) | — | — | 2024-07-01 | “Bio-Thera has filed BAT2206 for regulatory approval with EMA on 1 July 2024.” gedeonrichter.com ↗ |
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial · 1 met primary | ||||||
| Phase 1 | NCT04371185 | Aug 2020 → Apr 2021 | psoriasis | Bio-Thera Solutions | Completed | Met primary |
| Phase 31 trial | ||||||
| Phase 3 | NCT04728360 | Jul 2021 → Oct 2022 | psoriasis | Bio-Thera Solutions | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 2
| Date | Issuer | Release |
|---|---|---|
| 2025-08-27 | Gedeon Richter Ltd. | Regulatory The European Commission approves Bio-Thera’s BAT2206 (USYMRO®, a biosimilar ustekinumab), to be commercialized by Richter in Europe gedeonrichter.com ↗
Gedeon Richter announces today that the European Commission (EC) granted marketing authorization for BAT2206 (ustekinumab), a biosimilar – developed by Bio-Thera Solutions Inc. (“Bio-Thera”) – referencing Stelara®. |
| 2025-05-27 | Roxane Laboratories | Regulatory Bio-Thera Solutions and Hikma Pharmaceuticals announce FDA approval of STARJEMZA® (ustekinumab-hmny) Injection, a biosimilar referencing STELARA® (ustekinumab) Injection hikma.com ↗
The FDA approval of STARJEMZA®, originally known as BAT2206, was based on a comprehensive analytical, non-clinical, and clinical data package submitted by Bio-Thera to the FDA. |
All press releases naming this drug 3 releases
Evidence & citations 2 cited values
Every value below carries the sentence it was read from. 3 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | BAT2206 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04371185 ↗ |
| Route | Subcutaneous | “single subcutaneous injection (45 mg) of either BAT2206 or ustekinumab” PMID 36417156 ↗ Nov 2022 |