Drugs / BAT1806
Trials 3
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials · 1 met primary | ||||||
| Phase 1 | NCT05968508 | Aug 2023 → Oct 2024 | — | Bio-Thera Solutions | Completed | No outcome recorded |
| Phase 1 | NCT03606876 | Jun 2018 → Jul 2019 | rheumatoid arthritis | Bio-Thera Solutions | Completed | Met primary |
| Phase 31 trial · 1 met primary | ||||||
| Phase 3 | NCT03830203 | Dec 2018 → Jan 2021 | rheumatoid arthritis | Bio-Thera Solutions | Completed | Met primary |
News releases announcing trial results or a regulatory action · 7
| Date | Issuer | Release |
|---|---|---|
| 2024-06-24 | Biogen | Regulatory TOFIDENCE™ (tocilizumab), a Biosimilar Referencing ROACTEMRA®, Approved in the European Union biogen.com ↗
Biogen Inc. (Nasdaq: BIIB) announced that the European Commission (EC) has granted approval for TOFIDENCE TM , a biosimilar monoclonal antibody referencing ROACTEMRA ®1 . |
| 2024-04-25 | Biogen | Regulatory Biogen Receives Positive CHMP Opinion for TOFIDENCE™ (tocilizumab), a Biosimilar Referencing ROACTEMRA® biogen.com ↗ |
| 2023-09-29 | Biogen | Regulatory FDA Approves Biogen’s TOFIDENCE™ (tocilizumab-bavi), a Biosimilar Referencing ACTEMRA® biogen.com ↗
Biogen Inc. (Nasdaq: BIIB) announced that the U.S. Food and Drug Administration (FDA) has approved TOFIDENCE (tocilizumab-bavi) intravenous formulation, a biosimilar monoclonal antibody referencing ACTEMRA. |
| 2022-12-09 | Biogen | Regulatory FDA Accepts Biogen Biologics License Application for BIIB800, A Biosimilar Candidate Referencing ACTEMRA® (tocilizumab) biogen.com ↗
Biogen Inc. (Nasdaq: BIIB) – announced that the U.S. Food and Drug Administration (FDA) has accepted for review the abbreviated Biologics License Application (aBLA) for BIIB800, a biosimilar candidate referencing ACTEMRA® 1 (tocilizumab), an anti-interleukin-6 receptor monoclonal antibody. |
| 2022-09-30 | Biogen | Regulatory Biogen Announced EMA Filing Acceptance of BIIB800, A Biosimilar Candidate Referencing RoACTEMRA® (tocilizumab) biogen.com ↗
Biogen Inc. (Nasdaq: BIIB) announced that the European Medicines Agency (EMA) has accepted the Marketing Authorization Application (MAA) for BIIB800, a biosimilar candidate referencing RoACTEMRA ®1 (tocilizumab), an anti-interleukin-6 receptor monoclonal antibody. |
| 2022-06-03 | Biogen | Results Biogen and Bio-Thera Solutions Present Positive Phase 3 Data for Tocilizumab Biosimilar Candidate at the Annual European Congress of Rheumatology (EULAR 2022) biogen.com ↗
Data from the Phase 3 comparative clinical trial demonstrated that the investigational biosimilar candidate BIIB800 has equivalent efficacy and comparable safety and immunogenicity profile to the reference tocilizumab product. |
| 2021-06-01 | Biogen | Results Biogen and Bio-Thera Announce Positive Results From Phase 3 Study of BAT1806, a Proposed Biosimilar Referencing Actemra® (Tocilizumab) biogen.com ↗
The study met its primary endpoints, demonstrating equivalence to the reference medicine in patients with moderate to severe rheumatoid arthritis (RA) inadequately controlled by methotrexate therapy. |
All press releases naming this drug 7 releases
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 5 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | BAT1806 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05968508 ↗ |
| Known as | BAT1806 SC | “This study compared the pharmacokinetics (PK), safety, and immunogenicity of the Tocilizumab biosimilar, BAT1806 SC (Tocilizumab biosimilar, Subcutaneous Injection), with...” PMID 41069221 ↗ Oct 2025 |
| Known as | BIIB800 | “A phase 3, randomized, double-blind, active-controlled clinical trial to compare BAT1806/BIIB800, a tocilizumab biosimilar, with tocilizumab reference product in participants...” PMID 39244595 ↗ Sep 2024 |
| Route | Intravenous | “single intravenous drip” NCT03606876 ↗ |