Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
GP2017 Adalimumab · 1 trial · 1 indication
The primary variable was the PASI75 response rate at Week 16, defined as the proportion of patients achieving a reduction of 75% or more of the PASI score at Week 16 compared with baseline.
| Arm | Type | Description |
|---|---|---|
| GP2017 Adalimumab | EXPERIMENTAL | Study arm with intervention being studied in the protocol. Adalimumab Solution for subcutaneous injection with an initial dose of 80 mg s.c. in Week 0, followed by 40 mg s.c. eow, starting at Week 1 and ending at Week 51. |
| Humira ® Adalimumab | ACTIVE_COMPARATOR | Humira® Adalimumab as a subcutaneous injection with an initial dose of 80 mg s.c. in Week 0, followed by 40 mg s.c. eow, starting at Week 1 and ending at Week 51. |
| Name | Type | Description |
|---|---|---|
| GP2017 Adalimumab | DRUG | - |
| Humira ® Adalimumab | DRUG | - |
Inclusion Criteria: * Men or women at least 18 years of age at time of screening * Chronic plaque-type psoriasis diagnosed for at least 6 months before randomization * Moderate to severe psoriasis as defined at baseline by: * PASI score of 12 or greater * Investigator´s Global Assessment score...
GP2017 Adalimumab is a proposed biosimilar to Humira developed by Novartis AG. It is a monoclonal antibody studied in plaque type psoriasis. It is an investigational product that has completed Phase 3 clinical development.
GP2017 Adalimumab has been studied for the treatment of plaque type psoriasis. It is a biosimilar candidate referencing Humira and is not yet approved for any indication.
GP2017 Adalimumab is being developed by Novartis AG, which trades under the ticker NVS. Novartis is the sponsor of the clinical program evaluating this adalimumab biosimilar candidate.
GP2017 Adalimumab has completed a Phase 3 clinical trial. It remains an investigational biosimilar and is not approved by the FDA. The completed trial was an active-controlled, randomized, double-blind study.
GP2017 Adalimumab was evaluated in a single Phase 3 trial, NCT02016105, titled "Study to Demonstrate Equivalent Efficacy and to Compare Safety of Biosimilar Adalimumab (GP2017) and Humira." The trial enrolled 465 participants with plaque type psoriasis across the United States, Bulgaria, France, and Slovakia, and it is now completed.