Product Description
Ustekinumab biosimilar
Mechanisms of Action: IL12 Blocker, IL23 Blocker
Novel Mechanism: Yes
Modality: Antibody
Route of Administration: Injection
FDA Designation: *
Approval Status: Not Approved
Approved Countries: None
Approved Indications: None
Known Adverse Events: None
Company: Biocon Biologics
Company Location: Asia Pacific
Company Founding Year: None
Additional Commercial Interests: None
Clinical Description
Countries in Clinic: India, United States
Active Clinical Trial Count: 3
Recent & Upcoming Milestones
Highest Development Phases
Phase 3: Psoriasis
Trial ID |
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
Latest Trial Update Date |
Data Updated |
|---|---|---|---|---|---|---|---|---|
NCT06738277 |
Biosimilar Ustekinumab | P1 |
Completed |
Psoriasis |
2025-07-12 |
50% |
2025-08-20 |
Primary Endpoints |
2021-006668-25 |
STELLAR-2: Study to Test Efficacy and safety of biosimiLar ustekinumab to steLARa | P3 |
Active, not recruiting |
Psoriasis |
2024-06-12 |
|||
NCT05335356 |
STELLAR-2 | P3 |
Completed |
Psoriasis |
2023-01-26 |
6% |
2024-08-28 |
Primary Endpoints|Study Completion Date |
Recent News Events
Date |
Type |
Title |
|---|---|---|
|
03/07/2025 |
News Article |
Biocon Biologics Announces Positive Results from Phase 3 Study of Yesintek™ Biosimilar to Ustekinumab for Chronic Plaque Psoriasis |
|
12/02/2024 |
News Article |
U.S. FDA Approves Biocon Biologics' YESINTEK™, Bmab 1200 Biosimilar to J&J's Stelara® (Ustekinumab) |
|
09/25/2024 |
News Article |
Biocon Biologics Announces New Dermatology Data to Be Presented at EADV Congress 2024 |
|
08/29/2024 |
News Article |
Biocon Biologics Secures Market Entry for Bmab 1200, a Proposed Biosimilar to Stelara®, in Europe, UK, Canada, and Japan |