title: Biosimilar monoclonal antibodies in lymphoma: a critical appraisal.
abstract: Rituximab, an anti-CD20 monoclonal antibody, revolutionized the treatment of lymphoma. Although newer generation anti-CD20 monoclonal antibodies are being examined, patent expiries and patient demand have fueled the development of rituximab biosimilars. The development of such agents is both an important and difficult undertaking. By definition, although they aim to have safety and efficacy comparable with their reference agents, biosimilars are not exact replicas of those agents, and small changes in nonclinical and preclinical properties may ultimately affect in vivo activity. Consideration must be given to the complex mechanisms of action, sensitive patient populations that may be treated, and appropriate clinical trial endpoints. Furthermore, extrapolation of indications is multifaceted, deserving close examination. This review represents a critical look at biosimilars in lymphoma and their safety, efficacy and long-term effects on patient outcomes.
authors.affiliation: Hospices Civils de Lyon, Unité de Pharmacie Clinique Oncologique, Université de Lyon - EMR 3738, Pierre-Bénite, France.
authors.forename: Catherine
authors.initials: C
authors.lastname: Rioufol
authors.forename: Gilles
authors.initials: G
authors.lastname: Salles
mesh_terms: D000911:Antibodies, Monoclonal / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D018951:Antigens, CD20 / Q000276:immunology; D000970:Antineoplastic Agents / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use; D059451:Biosimilar Pharmaceuticals / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D002986:Clinical Trials as Topic / Q000379:methods; D023381:Endpoint Determination; D006801:Humans; D008223:Lymphoma / Q000188:drug therapy* / Q000473:pathology; D010330:Patents as Topic; D000069283:Rituximab / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use
chemical_list: D000911:Antibodies, Monoclonal; D018951:Antigens, CD20; D000970:Antineoplastic Agents; D059451:Biosimilar Pharmaceuticals; D000069283:Rituximab
keywords: Biosimilar; MabThera®; Rituxan®; biosimilar monoclonal antibody; lymphoma; non-Hodgkin lymphoma; rituximab