Agents currently in development with a view to attaining biosimilar status for treatment of rheumatic diseases
| Reference product | Manufacturer | Prospective biosimilar | Stage of development | Indication |
|---|---|---|---|---|
| Trials on-going in highly regulated markets (defined by EMA and FDA) | ||||
| Rituximab | Pfizer (USA) | PF-05280586 | Phase II (USA) | RA |
| Rituximab | Teva Pharmaceutical Industries (Israel) | TL011 | Phase II completed (EU). Phase III halted | RA |
| Rituximab | Samsung | SAIT 101 | Trials halted | RA |
| Rituximab | Sandoz Pharmaceuticals (Switzerland) | GP2013 | Preclinical (ACR2012) Phase II (EU, Argentina) | RA |
| Rituximab | Celltrion (South Korea) | CT-P10 | Phase I (South Korea) | RA |
| Rituximab | Boehringer Ingelheim | BI 695500 | Phase III (USA, EU, Norway, Ukraine, Argentina,Peru, New Zealand, | RA |
| Rituximab | Merck | MK8808 | Phase I (EU) | RA |
| Infliximab | Celltrion (South Korea) | CT-P13 | Approved (South Korea)/Phase 3 complete (EU) | RA;AS/RA |
| Phase I complete (EU, South Korea) | AS | |||
| Etanercept | Hanwha Chemical (South Korea) | HD203 | Phase III (South Korea) | RA |
| Etanercept | Mycenax Biotech (Taiwan) | TuNEX | Phase III (Japan and South Korea) | RA |
| Etanercept | LG Life Sciences Ltd (South Korea) | LBEC0101 | Phase I completed (South Korea) | Healthy subjects |
| Adalimumab | Boehringer Ingelheim Pharmaceuticals (Germany) | BI695501 | Phase I completed (New Zealand) | Healthy subjects |
| Trials on-going in less regulated markets | ||||
| Rituximab | Sandoz Pharmaceuticals (Switzerland) | GP2013 | Phase II: (India, Brazil) | RA |
| Rituximab | Boehringer Ingelheim | BI 695500 | Phase III (Brazil, Guatemala, Russian Federation) | RA |
| Rituximab | Merck | MK8808 | Phase I (Belarus) | RA |
| Preclinical | ||||
| Etanercept | Avesthagen (India) | Avent | Preclinical | |
| Etanercept | Protalix Biotherapeutics (Israel) | PRX-106 | Preclinical | |
Adapted by permission from Macmillan Publishers Ltd: (Nature reviews rheumatology),17 copyright (2012).
Additional information sourced from19–23.
AS, ankylosing spondylitis; EMA, European Medicines Agency; FDA, Food and Drug Administration; RA, rheumatoid arthritis.