Rituximab biosimilar by Celltrion for Waldenstrom Macroglobulinemia (Lymphoplasmacytic Lymphoma): Likelihood of Approval

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 overview

Rituximab 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.

Celltrion overview

Celltrion is a biopharmaceutical company that focuses on the research, development, and manufacture of biosimilars and novel biopharmaceuticals. The company offers monoclonal antibodies for the treatment of rheumatoid arthritis, ankylosing spondylitis, ulcerative colitis, adult Crohn’s disease, psoriatic arthritis, and psoriasis. Its pipeline portfolio spans monoclonal antibody biosimilars for the treatment of rheumatoid arthritis; colorectal cancer; and respiratory disease; and antibody biologics and vaccines for infectious diseases such as hepatitis B, influenza, rabies, breast cancer, and seasonal influenza. Celltrion develops drugs by using its bioengineering and mammalian cell-culture technology. The company also carries out contract manufacturing of biosimilars. It has an operational presence in Korea, Russia, the UK and the US. Celltrion is headquartered in Incheon, South Korea.

For a complete picture of Rituximab biosimilar’s drug-specific PTSR and LoA scores, buy the report here.

GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in clinical development (PTSR), as well as how likely the drug will be approved (LoA). This is based on a combination of machine learning and a proprietary algorithm to process data points from various databases found on GlobalData’s Pharmaceutical Intelligence Center.