Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
GP2013- A Proposed biosimilar rituximab · 1 trial · 1 indication
2006 NIAID/FAAN\* criteria were used for identification of anaphylactic reactions within 24h of each study drug infusion. For patients with no history of infusion-related reactions during their previous treatments with rituximab, symptoms/signs in at least 2 out of 4 organ systems: * Skin/mucosal tissue * Respiratory organs * Drop of systolic blood pressure (\<90 mmHg or variance from baseline \>30%) or associated symptoms * Gastrointestinal organs were defined as an anaphylactic reaction. The same criteria were also applied to patients with history of infusion-related reactions during their previous treatments with rituximab. In addition, if these patients experienced only a rapid drop in systolic blood pressure (\<90 mmHg or variance from baseline \>30%), this was defined as an anaphylactic reaction disregarding involvement of other organ systems. \* NIAID - National Institute of Allergy and Infectious Diseases FAAN - Food Allergy and Anaphylaxis Network
The standardized MedDRA query (SMQ) - Hypersensitivity reactions (SMQ 20000214) was used for the identification of hypersensitivity reactions overall from first infusion in the adverse event database.
Number of patients tested positive for anti-drug-antibodies (ADA) post-randomization. Patients with negative ADA results at screening and at least one evaluable post-randomization ADA assessment are included in the analysis
Patients, experienced infusion related reactions repeatedly (i.e. during the first and second infusion) are counted only once in the overall line.
| Arm | Type | Description |
|---|---|---|
| GP2013 - proposed biosimilar rituximab | EXPERIMENTAL | 10 mg/mL in 500 mg (50 mL) single-use vials. For i.v. administration, two 500 mg vials (1000 mg of active molecule) of concentrate are diluted in 0.9% NaCl solution and infused i.v. The treatment course consists of 2 i.v. infusions 2 weeks apart (at Day 1 and Day 14). |
| Originator rituximab - Rituxan ® or MabThera ® | ACTIVE_COMPARATOR | 10 mg/mL in 500 mg (50 mL) single-use vials. For i.v. administration two 500 mg vials (1000 mg of active molecule) of concentrate are diluted in 0.9% NaCl solution and infused i.v. The treatment course consists of 2 i.v. infusions 2 weeks apart (at Day 1 and Day 14). |
| Name | Type | Description |
|---|---|---|
| GP2013 - A Proposed biosimilar rituximab | BIOLOGICAL | - |
| Originator rituximab - Rituxan ® or MabThera ® | BIOLOGICAL | - |
Inclusion Criteria: * Diagnosis of rheumatoid arthritis (RA) according to ACR 2010 criteria * Completed one full treatment course with either Rituxan® or MabThera® * Eligible for a further treatment course with Rituxan® or MabThera®- Currently treated with methotrexate Exclusion Criteria: * RA fu...
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GP2013 is an investigational biosimilar of rituximab being developed for the treatment of rheumatoid arthritis. It is a monoclonal antibody intended to work in a similar way to the reference product Rituxan or MabThera. GP2013 is currently in clinical development and has not been approved by regulatory authorities.
GP2013 is a proposed biosimilar of rituximab, which targets the CD20 antigen on B cells. By binding to CD20, it is designed to deplete B cells, which are involved in the inflammatory process of rheumatoid arthritis. This mechanism is intended to reduce disease activity in patients with this condition.
GP2013 is being developed by Novartis AG, a global pharmaceutical company listed on the New York Stock Exchange under the ticker symbol NVS. Novartis is conducting clinical trials to evaluate the safety and efficacy of GP2013 as a biosimilar to rituximab for the treatment of rheumatoid arthritis.
GP2013 is in Phase 3 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory agencies. The Phase 3 trial for GP2013 has been completed, and the results will inform potential regulatory submissions for marketing authorization.
GP2013 has one completed Phase 3 clinical trial registered under NCT02514772. This trial, titled 'GP2013 Treatment in Patients With Active Rheumatoid Arthritis, Previously Treated With Rituxan® or MabThera®', enrolled 107 participants across the United States, Germany, Hungary, and Poland. The study was randomized, double-blind, and active-controlled.
GP2013 is a proposed biosimilar of rituximab, meaning it is designed to be highly similar to the reference biologic Rituxan or MabThera. While it is not identical, it is intended to have no clinically meaningful differences in terms of safety and efficacy. GP2013 is being developed as an alternative to the originator rituximab product.