title: Rituximab biosimilars.
abstract: BACKGROUND
  Rituximab is a monoclonal antibody targeting CD20, used to treat B cell malignancies and B cell-mediated autoimmune diseases. Rituximab has the largest market of any monoclonal antibody therapeutic. Its patent will expire within the next few years and several manufacturers have already produced or are developing rituximab biosimilars that aim to match the innovator rituximab as closely as possible.
  
  
  METHODS
  In this review, we discuss key factors that determine the efficacy of rituximab therapy, potential technical challenges in the manufacture and evaluation of biosimilars, regulatory considerations regarding the review and approval of biosimilars, and the current status of biosimilar rituximab development by various manufacturers. Due to the nature of the topic, literature searches included conference abstracts, regulatory and industry websites as well as peer reviewed literature.
  
  
  CONCLUSIONS
  Cost is a key limitation of current biologics usage and there is a political impetus to the licensing of biosimilars. Concerns regarding potential dissimilarities of biosimilars are legitimate, but surmountable with techniques for in vitro, in vivo and clinical testing and more clearly defined regulatory requirements. These should provide reassurance to prescribers. However, the cost of manufacturing and licensing a biosimilar remains high and the reduction in cost may be more limited than for a non-biologic small molecule drug and its generic version. This cost reduction will be critical to the impact and use of rituximab biosimilars.
authors.affiliation: Leeds Teaching Hospitals NHS Trust, NIHR Leeds Musculoskeletal Biomedical Research Unit, Leeds, UK. e.m.j.vital@leeds.ac.uk
authors.forename: Edward M
authors.initials: EM
authors.lastname: Vital
authors.forename: Jonathan
authors.initials: J
authors.lastname: Kay
authors.forename: Paul
authors.initials: P
authors.lastname: Emery
mesh_terms: D058846:Antibodies, Monoclonal, Murine-Derived / Q000627:therapeutic use*; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D059451:Biosimilar Pharmaceuticals / Q000592:standards* / Q000627:therapeutic use; D017277:Drug Approval; D006801:Humans; D009369:Neoplasms / Q000188:drug therapy*; D000069283:Rituximab
chemical_list: D058846:Antibodies, Monoclonal, Murine-Derived; D000970:Antineoplastic Agents; D059451:Biosimilar Pharmaceuticals; D000069283:Rituximab