Key study design elements for adalimumab biosimilar studies in plaque psoriasis*
| Company | Amgen | Sandoz/Novartis | Mylan | Coherus |
|---|---|---|---|---|
| Drug | ABP-501 | GP2017 | MYL-1401A | CHS-1420 |
| Disease activity | PASI≥12; BSA≥10%; sPGA≥3 | PASI≥12; BSA≥10%; GA≥3 | PASI≥12; BSA≥10%; sPGA≥3 | PASI≥12; BSA≥10%; sPGA≥3 |
| Previous biological therapy | Permitted (<2 agents) | Permitted | Permitted† | Previous anti-TNFα not permitted‡ |
| MTX treatment | Not permitted | Not permitted | Not permitted | Not permitted |
| Transition design§ | At week 16, Humira arm rerandomised to either Humira or ABP-501 | At week 16, Humira and GP2017 arms each rerandomised to Humira or GP2017 | Not specified in the synopsis | At week 16, Humira arm rerandomised to either Humira or CHS-1420 |
| Primary end point | Per cent PASI improvement from baseline at week 16 | PASI75 at week 16 | PASI75 at week 16 | PASI75 at week 12 |
*Study design information is summarised on the basis of information from the clinicaltrial.gov or EU clinical trial registry (see table 1 for NCT or EudraCT number), searched on 8 September 2015. All studies included in table 3 use an equivalence design.
†Previous adalimumab prohibited, while other biologics are not mentioned.
‡Previous anti-TNFα therapy is prohibited, while other biologics are not mentioned.
§In the main study or in the open-label extension study.
BSA, body surface area; EU, European Union; MTX, methotrexate; PASI75, 75% reduction in the Psoriasis Area and Severity Index score; sPGA, static physician's global assessment; TNF, tumour necrosis factor.