Rituximab biosimilar by Dr. Reddy’s Laboratories for Rheumatoid Arthritis: Likelihood of Approval

Rituximab biosimilar is under clinical development by Dr. Reddy’s Laboratories and currently in Phase III for Rheumatoid Arthritis. According to GlobalData, Phase III drugs for Rheumatoid Arthritis have a 65% phase transition success rate (PTSR) indication benchmark for progressing into Pre-Registration. 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 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.

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