Drugs / Bmab 1200
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT06738277 | Jan → Jul 2025 | psoriasis | Biocon Biologics UK Ltd | Completed | No outcome recorded |
| Phase 31 trial · 1 met primary | ||||||
| Phase 3 | NCT05335356 | Jun 2022 → Jan 2023 | psoriasis | Biocon Biologics UK Ltd | Completed | Met primary |
News releases announcing trial results or a regulatory action · 4
| Date | Issuer | Release |
|---|---|---|
| 2025-05-25 | Biocon Biologics UK Ltd | Regulatory Biocon Biologics Receives MHRA, UK Approval for YESINTEK®, Biosimilar Ustekinumab bioconbiologics.com ↗
In Europe, the European Commission (EC) recently granted marketing authorisation for Ustekinumab, allowing its commercialization in all European Union (EU) member states and the European Economic Area (EEA). |
| 2025-02-18 | Biocon Biologics UK Ltd | Regulatory European Commission Approves Biocon Biologics’ Ustekinumab Biosimilar bioconbiologics.com ↗
The marketing authorisation approval follows a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) issued on December 14, 2024. |
| 2024-12-15 | Biocon Biologics UK Ltd | Regulatory EMA’s CHMP recommends approval of Biocon Biologics’ YESINTEK®, biosimilar to J&J’s Stelara® bioconbiologics.com ↗
The CHMP positive opinion follows recent approval by the U.S. FDA earlier this month. |
| 2024-12-01 | Biocon Biologics UK Ltd | Regulatory U.S. FDA Approves Biocon Biologics’ YESINTEK™, Bmab 1200 biosimilar to J&J’s Stelara® (Ustekinumab) bioconbiologics.com ↗
YESINTEK™ , a monoclonal antibody, is approved for the treatment of Crohn’s disease, Ulcerative Colitis, Plaque Psoriasis and Psoriatic Arthritis. |
All press releases naming this drug 8 releases
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 3 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Bmab 1200 | “Efficacy and safety of the ustekinumab biosimilar, Bmab 1200, versus reference ustekinumab in moderate-to-severe plaque psoriasis: 28‑week results of the randomized,...” PMID 40708530 ↗ Jul 2025 |
| Known as | Ustekinumab | “Bmab 1200 (Biosimilar Ustekinumab)” NCT06738277 ↗ |
| Route | Subcutaneous | “Route of Administration: Subcutaneous” NCT06738277 ↗ |