Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Experimental: Arm A: DRL_RI · 1 trial · 1 indication
For Immunogenicity: Number of subjects with positive Anti-Drug Antibodies (ADA) on Day 1 was reported
For Immunogenicity: Number of subjects with positive Anti-Drug Antibodies (ADA) on Day 15 was reported
For Immunogenicity: Number of subjects with positive Anti-Drug Antibodies (ADA) at Week 4 was reported
For Immunogenicity: Number of subjects with positive Anti-Drug Antibodies (ADA) at Week 8 was reported
For Immunogenicity: Number of subjects with positive Anti-Drug Antibodies (ADA) at Week 12 visits was reported
| Arm | Type | Description |
|---|---|---|
| Arm A: DRL_RI | EXPERIMENTAL | Subjects who have already received at least 1 full course comprising two 1000 mg infusions of either US-rituximab or EU-rituximab and are candidates for re-treatment with Rituximab, will be enrolled. DRL\_RI will be administrated in combination with MTX as two 1000 mg infusions on Day 1 and Day 15 |
| Arm B: US-Rituximab or EU-Rituximab | ACTIVE_COMPARATOR | Subjects who have already received at least 1 full course comprising two 1000 mg infusions of either US-rituximab or EU-rituximab and are candidates for re-treatment with rituximab, will be enrolled. Patients enrolled in Arm -B will continue to receive US-rituximab or EU-rituximab. The rituximab reference product used (US-licensed rituximab \[Rituxan\] or EU-approved rituximab \[MabThera\]) should be the same in the prior and the randomized treatment course, respectively. |
| Name | Type | Description |
|---|---|---|
| Experimental: Arm A: DRL_RI | BIOLOGICAL | Proposed rituximab biosimilar, 100mg or 500mg, concentrate for solution for infusion |
| Arm B: Rituxan®/Mabthera® | BIOLOGICAL | Reference product US- rituximab (Rituxan®) or EU-rituximab (MabThera®), 100mg or 500mg, concentrate for solution for infusion |
Inclusion Criteria: 1. Male or female subjects aged 18 years or older who have provided valid written informed consent. 2. Subjects with a diagnosis of active RA who are eligible for the subsequent treatment course with US-rituximab or EU-rituximab according to the clinical judgment of the investig...
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DRL_RI is an investigational monoclonal antibody being studied for the treatment of Rheumatoid Arthritis. It is a proposed biosimilar to rituximab, developed by Dr. Reddy's Laboratories Ltd. The drug is currently in Phase 3 clinical development, with one completed trial evaluating its efficacy and safety in patients with this condition.
DRL_RI targets CD20, a protein found on the surface of B cells. By binding to CD20, the antibody is designed to deplete B cells, which are involved in the inflammatory process of Rheumatoid Arthritis. This mechanism is similar to that of the reference rituximab product, which DRL_RI is being developed to mimic.
DRL_RI is being developed by Dr. Reddy's Laboratories Ltd, a pharmaceutical company listed on the stock exchange under the ticker RDY. The company is conducting clinical trials to evaluate the drug as a potential biosimilar to rituximab for the treatment of Rheumatoid Arthritis.
DRL_RI is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. A Phase 3 trial has been completed, but the drug remains under investigation and is not yet available for clinical use outside of clinical trials.
DRL_RI has been studied in one clinical trial, identified as NCT04268771. This was a Phase 3, randomized, double-blind, active-controlled study titled 'A Phase III Transition Study of DRL Rituximab to Reference Medicinal Products.' The trial enrolled 140 participants with Rheumatoid Arthritis in the United States and has been completed.
DRL_RI is a proposed biosimilar to rituximab, meaning it is designed to be highly similar to the reference product but is not identical. It is being developed to match the efficacy and safety of rituximab for the treatment of Rheumatoid Arthritis. The drug is still investigational and has not been approved as a biosimilar.