Rituximab biosimilar is under clinical development by Dr. Reddy’s Laboratories and currently in the Phase III in clinical pathway. The characteristics of the clinical trial as well as other attributes related to the drug, regulations, and company play a fundamental role in ensuring the likelihood of transition that the drug moves from its current development stage to next.

According to GlobalData, the latest event to affect Rituximab biosimilar’s likelihood of approval (LoA) and phase transition for Follicular Lymphoma took place on 06 Jun 2022, which increased the likelihood that the drug progresses to the next phase in its clinical pathway and increased the likelihood of final approval for this indication.

GlobalData uses proprietary data and analytics to provide a complete picture of this assessment in their Rituximab biosimilar Likelihood of Approval (LoA) and Phase Transition Success Rate (PTSR) Report.

Rituximab biosimilar overview

Rituximab biosimilar (Reditux) is an antineoplastic agent, biological response modifier. Reditux is a 144 kDa mouse/human monoclonal antibody consisting of a glycosylated IgG1kappa immunoglobulin with murine light-and-heavy chain variable regions (Fab) and human kappa and gamma1 constant regions (Fc domain). It is produced using recombinat DNA technology in Chinese Hamster Ovary (CHO) cells. It is formulated as solution and concentrated solution for infusion for intravenous route of administration. Reditux is indicated for the treatment of non-Hodgkin lymphoma.

Rituximab biosimilar is under development for the treatment of previously untreated follicular lymphoma and rheumatoid arthritis in the U.S and EU.

Dr. Reddy’s Laboratories overview

Dr. Reddy’s Laboratories (Dr. Reddy’s) is a pharmaceutical company that manufactures and markets generic formulations, active pharmaceutical ingredients (APIs), biosimilars and proprietary products. The company’s generic products are indicated for the treatment of gastrointestinal disorders, various cancer types, cardiovascular diseases, pain, central nervous system disorders, infectious diseases, and pediatric diseases. The company also develops and markets generic biosimilar products. Its pipeline includes New Chemical Entities (NCEs) that focus on the treatment of metabolic disorders, bacterial infections, pain, and inflammation. The company markets products in the US, Europe, Latin America, and Asia. Dr. Reddy’s is headquartered in Hyderabad, Telangana, India.

Quick View Rituximab biosimilar LOA Data

Report Segments
  • Biosimilar
Drug Name
  • Rituximab biosimilar
Administration Pathway
  • Intravenous
Therapeutic Areas
  • Immunology
  • Oncology
Key Developers
Highest Development Stage
  • Marketed

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 its clinical pathway (PTSR), as well as how likely the drug will be approved (LoA). This is based on a proprietary algorithm built from the drugs’ sales forecast, regulatory milestones, cost forecasts, WACC rate and other proprietary data sources found on GlobalData’s Pharmaceutical Intelligence Center.