Rituximab biosimilar by Celltrion for Waldenstrom Macroglobulinemia (Lymphoplasmacytic Lymphoma): Likelihood of Approval
Rituximab biosimilar is under clinical development by Celltrion and currently in Phase II for Waldenstrom Macroglobulinemia (Lymphoplasmacytic Lymphoma). According to GlobalData, Phase II drugs for Waldenstrom Macroglobulinemia (Lymphoplasmacytic Lymphoma) have a 26% phase transition success rate (PTSR) indication benchmark for progressing into Phase III. GlobalData's report assesses how Rituximab biosimilar's drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks. Buy the report here.GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.Rituximab biosimilar overviewRituximab biosimilar (Truxima/Blitzima/Tuxella/Ritemvia/Rituzena) is an anti-tumor malignant agent. It is formulated as concentrate solution for intravenous route of administration. Rituximab biosimilar is indicated in adults for the treatment of previously untreated patients with stage III-IV follicular lymphoma in combination with chemotherapy, maintenance therapy is indicated for the treatment of follicular lymphoma patients responding to induction therapy, monotherapy is indicated for treatment of patients with stage III-IV follicular lymphoma who are chemo-resistant or are in their second or subsequent relapse after chemotherapy for the treatment of patients with CD20 positive diffuse large B cell non-Hodgkin’s lymphoma in combination with CHOP (cyclophosphamide, doxorubicin, vincristine, prednisolone) chemotherapy, Truxima in combination with chemotherapy is indicated for the treatment of patients with previously untreated and relapsed/refractory CLL. Truxima in combination with methotrexate is indicated for the treatment of adult patients with severe active rheumatoid arthritis who have had an inadequate response or intolerance to other disease-modifying anti-rheumatic drugs (DMARD) including one or more tumour necrosis factor (TNF) inhibitor therapies.Truxima, in combination with glucocorticoids, is indicated for the induction of remission in adult patients with severe, active granulomatosis with polyangiitis (Wegener’s) (GPA) and microscopic polyangiitis (MPA), Truxima is indicated in adults with relapsed or refractory, low grade or follicular, CD20-positive B-cell NHL as a single agent, previously untreated follicular, CD20-positive, B-cell NHL in combination with first line chemotherapy and, in patients achieving a complete or partial response to a rituximab product in combination with chemotherapy, as single-agent maintenance therapy, and on-progressing (including stable disease), low-grade, CD20 positive, B-cell NHL as a single agent after first-line cyclophosphamide, vincristine and prednisone (CVP) chemotherapy. Truxima in combination with methotrexate is indicated for the treatment of adult patients with moderate to severe active rheumatoid arthritis who have had an inadequate response to one or more TNF antagonist therapies. In combination with glucocorticoids Truxima is also indicated for the treatment of adult patients with Granulomatosis with Polyangiitis (GPA) (Wegener’s Granulomatosis) and Microscopic Polyangiitis (MPA). Rituximab biosimilar is under development for the treatment of Waldenstrom macroglobulinemia, B-cell non-Hodgkin lymphoma and primary CNS lymphoma. It was also under development for diffuse large B-cell lymphoma. For a complete picture of Rituximab biosimilar's drug-specific PTSR and LoA scores, buy the report here.
Rituximab biosimilar is under clinical development by Celltrion and is currently in the Phase II in clinical pathway.
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