Table 4

Agents currently in development with a view to attaining biosimilar status for treatment of rheumatic diseases

Reference productManufacturerProspective biosimilarStage of developmentIndication
Trials on-going in highly regulated markets (defined by EMA and FDA)
 RituximabPfizer (USA)PF-05280586Phase II (USA)RA
 RituximabTeva Pharmaceutical Industries (Israel)TL011Phase II completed (EU). Phase III haltedRA
 RituximabSamsungSAIT 101Trials haltedRA
 RituximabSandoz Pharmaceuticals (Switzerland)GP2013Preclinical (ACR2012)
Phase II (EU, Argentina)
 RituximabCelltrion (South Korea)CT-P10Phase I (South Korea)RA
 RituximabBoehringer IngelheimBI 695500Phase III (USA, EU, Norway, Ukraine, Argentina,Peru, New Zealand,RA
 RituximabMerckMK8808Phase I (EU)RA
 InfliximabCelltrion (South Korea)CT-P13Approved (South Korea)/Phase 3 complete (EU)RA;AS/RA
Phase I complete (EU, South Korea)AS
 EtanerceptHanwha Chemical (South Korea)HD203Phase III (South Korea)RA
 EtanerceptMycenax Biotech (Taiwan)TuNEXPhase III (Japan and South Korea)RA
 EtanerceptLG Life Sciences Ltd (South Korea)LBEC0101Phase I completed (South Korea)Healthy subjects
 AdalimumabBoehringer Ingelheim Pharmaceuticals (Germany)BI695501Phase I completed (New Zealand)Healthy subjects
Trials on-going in less regulated markets
 RituximabSandoz Pharmaceuticals (Switzerland)GP2013Phase II: (India, Brazil)RA
 RituximabBoehringer IngelheimBI 695500Phase III (Brazil, Guatemala, Russian Federation)RA
 RituximabMerckMK8808Phase I (Belarus)RA
 EtanerceptAvesthagen (India)AventPreclinical
 EtanerceptProtalix Biotherapeutics (Israel)PRX-106Preclinical
  • 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.