Studies of reference and biosimilar infliximab, etanercept, adalimumab, and rituximab incorporating a switch protocol
| Innovator | Biosimilar | Sponsor study name (trial registration) | Study design | Indication(s) | Number of patients | Switches/ patient | Follow-up post-switch |
| Infliximab | CT-P13 | PLANETRA (NCT01217086) | OL extension to phase III DB RCT | RA | 302 | 1 | 48 weeks |
| Infliximab | CT-P13 | PLANETAS (NCT01220518) | OL extension to phase I DB RCT | AS | 174 | 1 | 48 weeks |
| Infliximab | CT-P13 | (JapicCTI-142419) Tanaka | OL extension to phase I/II RCT | RA | 71 | 1 | 134 weeks |
| Infliximab | CT-P13 | Database analysis | RA | 3018 | 1 | Variable | |
| Infliximab | CT-P13 | DANBIO | Registry analysis | RA, PsA, AxSpA | 792 | 1 | 11 months |
| Infliximab | CT-P13 | Single-centre study | RA, AS, PsA, enteropathic arthritis | 56 | 1 | Variable | |
| Infliximab | CT-P13 | Single-centre study | AS, enteropathic arthritis, PsA, undifferentiated SpA | 41 | 1 | 26 weeks | |
| Infliximab | CT-P13 | Single-centre study | RA, SpA, PsA, JRA, chronic reactive arthritis | 39 | 1 | Variable | |
| Infliximab | CT-P13 | Single-centre study | Inflammatory arthritis | 34 | 1 | n/a | |
| Infliximab | CT-P13 | Single-centre study | RA, AS, PsA | 30 | 1 | n/a | |
| Infliximab | CT-P13 | BIO-SWITCH (NTR5279) | Observational OL, phase IV | RA, SpA, PsA | 192 | 1 | 52 weeks |
| Infliximab | CT-P13 | Single-centre study | CD, UC | 143 | 1 | 6 months | |
| Infliximab | CT-P13 | Single-centre MSP | IBD | 134 | 1 | 16 weeks | |
| Infliximab | CT-P13 | Retrospective OL | CD, UC | 110 | 1 | Variable | |
| Infliximab | CT-P13 | Observational cohort | CD, IBD, UC | 83 | 1 | 16 weeks | |
| Infliximab | CT-P13 | Single-centre study | CD | 75 | 1 | 26 weeks | |
| Infliximab | CT-P13 | Prospective | CD, UC | 74 | 1 | 24 weeks | |
| Infliximab | CT-P13 | Single-centre study | UC | 40 | 1 | 26 weeks | |
| Infliximab | CT-P13 | Observational OL (transition design 2) | Paediatric CD and US | 39 | 1 | 32 weeks | |
| Infliximab | CT-P13 | Single-centre study | CD, UC | 25 | 1 | 48 | |
| Infliximab | CT-P13 | Retrospective OL | CD, UC | 17 | 1 | n/a | |
| Infliximab | CT-P13 | Observational | CD, UC | 397 | n/a | Variable | |
| Infliximab | CT-P13 | OL, phase 4 | CD, FCD, UC | 173 | 1 | 30 weeks | |
| Infliximab | CT-P13 | Single-centre study | PsO | 35 | 1 | Variable | |
| Infliximab | CT-P13 | NOR-SWITCH (NCT02148640) | DB RCT, phase 4 | RA, SpA, PsA, UC, CD, PsO | 481 | 1 | 52 weeks |
| Infliximab | CT-P13 | Single-centre study | PsA, AS, RA, CD, Beçhet’s disease | 23 | 1 | n/a | |
| Infliximab | CT-P13 | (JapicCTI-142,703) | OL extension to phase IV RCT | RA | n/a | 1 | n/a |
| Infliximab | CT-P13 | SIMILAR (2015–001 954–14) | Phase IV DB RCT, OL extension planned | UC, CD | 182 | 1 | 30 weeks |
| Infliximab | CT-P13 | (NCT02096861) | DB, RCT, phase III | CD | 220 | n/a | n/a |
| Infliximab | CT-P13 | CONNECT-IBD (NCT02539368) | Observational, phase IV | CD, UC | n/a | n/a | n/a |
| Infliximab | CT-P13 | SECURE (2014-004904-31) | OL (no comparator), phase IV | RA, UC, CD | n/a | 1 | 16 weeks |
| Infliximab | SB2 | (NCT01936181) | DB RCT, phase III | RA | 396 | 1 | 24 weeks |
| Infliximab | Infliximab NK | Single-centre | UC, CD | 20 | 1 | 22 weeks | |
| Infliximab | Unspecified | Retrospective OL | IBD | 72 | 1 | 26 weeks | |
| Infliximab | Unspecified | (UMIN 000021492) | OL single-centre study | RA | 40 | 1 | n/a |
| Etanercept | SB4 | (NCT01895309) | OL extension of phase III RCT | RA | 245 | 1 | 48 weeks |
| Etanercept | SB4 | (NCT01865552) | SB RCT, phase III | — | 138 | 1 | 28 days |
| Etanercept | SB4 | BIO-SPAN (NTR5901) | OL single-centre study | Rheumatic disease | 500 | 1 | 52 weeks |
| Etanercept | GP2015 | EGALITY (NCT01891864 2012-0020011-26) | DB RCT, phase III | PsO | 531 | 3 | 40 weeks |
| Etanercept | GP2015 | DB RCT, phase I | — | 54 | 1 | 28 days | |
| Etanercept | GP2015 | EQUIRA (2012-002009-23) | DB RCT, phase III | RA | 366 | 1 | 24 weeks |
| Etanercept | HD203 | (NCT01431404) | DB SD crossover, phase I | — | 42 | 1 | 21 days |
| Etanercept | CHS-0214 | RApsody (NCT02115750) | DB RCT, phase III | RA | 647 | 1 | n/a |
| Etanercept | LBEC0101 | (NCT01725620) | DB SD crossover, phase I | — | 48 | 1 | 27 days |
| Etanercept | LBEC0101 | (NCT01145950) | DB SD crossover, phase I | — | 36 | 1 | 22 days |
| Etanercept | LBEC0101 | (NCT02715908) | OL extension of phase III RCT | RA | 165 | 1 | 48 weeks |
| Etanercept | TuNEX | (ICTRP KCT0000118) | OL SD crossover, phase I | — | 23 | 1 | 21 days |
| Adalimumab | ABP 501 | (NCT02114931) | OL extension of phase III RCT | RA | 467 | 1 | 48 weeks |
| Adalimumab | ABP 501 | (NCT01970488) | DB RCT, phase III | PsO | 350 | 1 | 36 weeks |
| Adalimumab | SB5 | (NCT02167139) | DB RCT, phase III | RA | 273 | 1 | 28 weeks |
| Adalimumab | M923 | (2015-001751-76) | DB RCT, phase III | PsO | 516 | Multiple | 13 weeks |
| Rituximab | CT-P10 | (NCT01873443) | OL extension to phase I RCT | RA | 87 | 1 | 56 weeks |
| Rituximab | GP2013 | ASSIST-RT (NCT02514772) | DB RCT, phase III | RA | 107 | 1 | 12 weeks |
Table 3 is adapted from Moots R, Azevedo V, Coindreau JL, et al. Switching between reference biologics and biosimilars for the treatment of rheumatology, gastroenterology, and dermatology inflammatory conditions: considerations for the Clinician. Curr Rheumatol Rep 2017;19:37.