Table 1.
Profile of clinical trials on etanercept biosimilars according to international regulations
| Sponsor | Biosimilar | Condition | Phase | Estimated recruitment | Experimental design | Dose (mg) | Parameter | References |
|---|---|---|---|---|---|---|---|---|
| Samsung Bioepis | SB4 | RA (−+) | III | 498 | SB4 versus etanercept | 50 | S, E | NIH [113] |
| Samsung Bioepis | SB4 | Healthy | I | 138 | SB4 versus etanercept (EU) and etanercept (US) | 50 | PK, S, I | NIH [114] |
| Sandoz | GP2015 | Ps | III | 372 | GP2015 versus etanercept | 50 | E | NIH [115] |
| TSH Biopharm Corporation | TuNEX®/ENIA11 | RA, MX | III | 129 | TuNEX® versus MTX and Placebo | 15–25 | S, E, I | Gu et al. [91], Chen et al. [116] |
| LG Life Sciences | LBEC0101 | Healthy | I | 36 | LBEC0101 versus etanercept | 25 | PK | NIH [117] |
| Daewoong Pharmaceutical | DWP422 | RA | I | 38 | DWP422 versus etanercept | 25 | PK, S | NIH [118] |
| Hanwha Chemical | HD203 | Healthy | I | 44 | HD203 versus etanercept | 25 | PK | [90] |
| Coherus Biosciences Inc/Baxter and Daiichi Sankyo | CHS-0214 | Healthy | I | – | CHS-0214 versus etanercept | – | PK | Yi et al. [119] |
| Bionovis (Merck Serono) | – | – | – | 318 | unknown versus etanercept | – | E | Scaramuzzo [92], Brazilian Ministry of Health [93] |
Pk pharmacokinetic, MTX methotrexate, RA (−+) moderate and severe rheumatoid arthritis, S safety, E efficacy, I immunogenicity