Summary of global phase III clinical efficacy studies for biosimilar adalimumab*
| Company | IMP | Indication | Study start† | Status | Number of patients | NCT and/or EudraCT number |
|---|---|---|---|---|---|---|
| Amgen | ABP-501 | PsO | 2013 | Completed | 350 | NCT01970488 |
| RA | 2013 | Completed | 526 | NCT01970475 | ||
| Boehringer Ingelheim | BI 695501 | RA | 2014 | Recruiting | 650 | NCT02137226 2012-002945-40 |
| Fuji Film Kyowa Kirin Biologics | FKB327 | RA | 2014 | Recruiting | 600 | NCT02260791 2014-000109-11 |
| Pfizer | PF-06410293 | RA | 2014 | Recruiting | 560 | NCT02480153 2014-000352-29 |
| Samsung Bioepis | SB5 | RA | 2014 | Completed | 490 | NCT02167139 2013-005013-13 |
| Sandoz/Novartis | GP2017 | PsO | 2013 | Ongoing, not recruiting | 448 | NCT02016105 2013-000747-11 |
| Biocon, Mylan Inc | MYL-1401A | PsO | 2015 | Recruiting | 294 | 2014-003420-46 |
| Coherus biosciences | CHS-1420 | PsO | 2015 | Recruiting | 500 | NCT02489227 2015-000632-15 |
*Studies included ongoing and completed global trials based on information from Citeline's Trialtrove as of 8 September 2015, and confirmed from clinicaltrials.gov (trials with the numbers starting with NCT) and/or the EU registry (trials with numbers starting with the year, eg, 2012), searched on 8 September 2015.
†If there is any difference in the start date from clinialtrials.gov versus the EU registry, the earlier date is included.
EU, European Union; IMP, Investigational Medicinal Product; NCT, National Clinical Trial; PsO, plaque psoriasis; RA, rheumatoid arthritis.