Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
GP2015 Etanercept · 1 trial · 1 indication
The 95% CI for the Psoriasis Area and Severity Index (PASI) 75 response rate differences at Week12 between GP2015 Etanercept and Enbrel ® Etanercept. PASI 75 response: patients who achieved ≥ 75% improvement (reduction) in PASI score compared to baseline were defined as PASI 75 responders. PASI scores can range from 0, corresponding to no signs of psoriasis up to theoretic maximum of 72.0, which means a higher PASI score reflects a higher psoriasis activity.
| Arm | Type | Description |
|---|---|---|
| GP2015 Etanercept | EXPERIMENTAL | Solution for subcutaneous injection in pre-filled syringe. The drug is administered in a dose of 50 mg twice weekly for the first 12 weeks and 50 mg once weekly thereafter |
| Enbrel ® Etanercept | ACTIVE_COMPARATOR | Solution for subcutaneous injection in pre-filled syringe. The drug is administered in a dose of 50 mg twice weekly for the first 12 weeks and 50 mg once weekly thereafter |
| Name | Type | Description |
|---|---|---|
| GP2015 Etanercept | DRUG | Sandoz has developed GP2015 Etanercept (Sandoz's code for the drug product containing the active ingredient etanercept) to be biosimilar to Enbrel. |
| Enbrel | DRUG | Enbrel is used as reference product to GP2015. |
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 baseline * Moderate to severe psoriasis as defined at baseline by: * PASI score of 10 or greater and, * Investigator´s Global Assessment score...
GP2015 Etanercept is used for the treatment of chronic stable plaque psoriasis, a skin condition characterized by raised, inflamed, and scaly patches. It is being developed as a biosimilar to Enbrel, with the goal of demonstrating equivalent efficacy and comparable safety in patients with this condition.
GP2015 Etanercept is being developed by Novartis AG, a multinational pharmaceutical company headquartered in Basel, Switzerland. Novartis is listed on the stock exchange under the ticker symbol NVS.
GP2015 Etanercept is in Phase 3 clinical development. It is an investigational drug and has not yet been approved by regulatory authorities. The Phase 3 trial has been completed, and the results will inform potential regulatory submissions for approval.
GP2015 Etanercept has been studied in one Phase 3 clinical trial with the identifier NCT01891864. This trial, titled 'Study to Demonstrate Equivalent Efficacy and to Compare Safety of Biosimilar Etanercept (GP2015) and Enbrel', enrolled 531 participants with chronic stable plaque psoriasis and has been completed.
GP2015 Etanercept is a biosimilar to Enbrel, meaning it is designed to be highly similar to the reference biologic Enbrel. The Phase 3 trial was conducted to demonstrate equivalent efficacy and comparable safety between GP2015 Etanercept and Enbrel in patients with chronic stable plaque psoriasis.
GP2015 Etanercept is a biosimilar to etanercept, which works by binding to tumor necrosis factor (TNF), a cytokine involved in systemic inflammation. By neutralizing TNF, it reduces the inflammatory response that contributes to the development of psoriatic plaques.