Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Experimental: Arm A: DRL_RI, DRL_RI (Proposed rituximab biosimilar)
DRL_RI · 3 trials · 2 indications
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
Best Overall Response Rate (BORR) is defined as the proportion of participants in each treatment group that achieved a best overall response of either Complete response (CR), unconfirmed Complete response (CRu) or Partial response (PR), up to Month 7 (Week 28) based on central radiology review in accordance with the Cheson, 1999 response criteria for Non-Hodgkin's Lymphomas. As per Cheson 1999, response criteria for target lesions and assessed by radiology: Complete response (CR): All lesions with a longest diameter should be regressed to normal size (≤ 15 mm) or short axis regressed to ≤ 10 mm with confirmed Bone marrow normalization; unconfirmed Complete response (CRu): All lesions with a longest diameter should be regressed to normal size (≤ 15 mm) or short axis regressed to ≤ 10 mm with non-confirmed Bone marrow normalization; Partial Response (PR): ≥ 50 % decrease of sum of products of diameter(SPD) of all the target lesions; Overall Response (OR)=CR+CRu+PR.
PK samples were collected pre-infusion; 3 hours post infusion; EOI; and at 1, 6, 24, 48, 168 hours post End of Infusion. A PK sample at 336 hours post EOI were also to be collected after the second dose.
PK samples were collected pre-infusion; 3 hours post infusion; EOI; and at 1, 6, 24, 48, 168 hours post End of Infusion. A PK sample at 336 hours post EOI were also to be collected after the second dose.
PK samples were collected pre-infusion; 3 hours post infusion; EOI; and at 1, 6, 24, 48, 168 hours post End of Infusion. A PK sample at 336 hours post EOI were also to be collected after the second dose
| 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. |
| Arm B: MabThera® | ACTIVE_COMPARATOR | MabThera® for infusion 375 mg/m2 administered via IV infusion on Days 1, 8, 15, 22 and Week 12, 20, 28 and 36. |
| DRL_RI | EXPERIMENTAL | - |
| Rituxan | ACTIVE_COMPARATOR | - |
| MabThera | ACTIVE_COMPARATOR | - |
| 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 |
| DRL_RI (Proposed rituximab biosimilar) | BIOLOGICAL | Proposed rituximab biosimilar, 100mg and 500mg, concentrate for solution for infusion |
| MabThera® | OTHER | Reference product rituximab, 100mg and 500mg, concentrate for solution for infusion |
| DRL_RI | BIOLOGICAL | Two 1000 mg intravenous infusions, one each on Day 1 and Day 15 |
| Rituxan | BIOLOGICAL | Two 1000 mg intravenous infusions, one each on Day 1 and Day 15 |
| MabThera | BIOLOGICAL | Two 1000 mg intravenous infusions, one each on Day 1 and Day 15 |
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...
DRL_RI is an investigational monoclonal antibody developed by Dr. Reddy's Laboratories Ltd as a proposed rituximab biosimilar. It is being studied in Phase 3 clinical trials for follicular lymphoma and rheumatoid arthritis. DRL_RI is designed to be a biosimilar to the reference rituximab product, MabThera.
DRL_RI is being developed for the treatment of follicular lymphoma, a type of non-Hodgkin lymphoma. A Phase 3 trial (NCT03976102) compared the efficacy, safety, and immunogenicity of DRL_RI with MabThera in patients with low tumor burden follicular lymphoma. The trial has been completed.
DRL_RI targets CD20, a protein found on the surface of B cells. As a monoclonal antibody, it binds to CD20 and is designed to induce B-cell depletion. This mechanism is similar to that of rituximab, the reference product.
DRL_RI is being developed by Dr. Reddy's Laboratories Ltd, a pharmaceutical company based in India. The company's stock ticker is RDY. Dr. Reddy's is developing DRL_RI as a proposed biosimilar to rituximab.
DRL_RI is in Phase 3 clinical development. Two Phase 3 trials have been completed: one in rheumatoid arthritis (NCT04268771) and one in follicular lymphoma (NCT03976102). A Phase 1 trial (NCT02296775) in rheumatoid arthritis has also been completed. DRL_RI is investigational and not approved by the FDA.
DRL_RI has been studied in three completed clinical trials. The Phase 3 trials are NCT04268771 in rheumatoid arthritis and NCT03976102 in follicular lymphoma. A Phase 1 trial, NCT02296775, compared three anti-CD20 monoclonal antibodies in rheumatoid arthritis. All trials are completed.
DRL_RI is a proposed rituximab biosimilar, meaning it is designed to be highly similar to the reference rituximab product, MabThera. It is not identical to rituximab but is intended to have comparable safety and efficacy. DRL_RI is also known as DRL_RI (Proposed rituximab biosimilar).