title: Should therapeutic immunoglobulin be considered a generic product? An evidence-based approach.
abstract: The increasing therapeutic use of intravenous immunoglobulin (IVIG) for an expanding range of indications, from immunodeficiency to autoimmune disease coupled with the availability of multiple products has prompted debate on whether IVIG products should be considered to be generic. Although the manufacturing process and associated excipients for individual products varies, all currently licensed IVIG products are composed predominantly of IgG (>95%) and comply with the quality standards of regulatory agencies. Because these products have a licence for a common group of indications, does that mean that all of them are equally efficacious in the treatment of the same disease? In vitro data and published evidence of head-to-head trials of IVIG in primary antibody deficiency, immune thrombocytopenic purpura, and chronic inflammatory demyelinating polyneuropathy suggest that different IVIG products are likely to be equally efficacious in terms of clinical efficacy. Consequently, it would be reasonable to consider IVIG products to be generic in terms of clinical outcomes. However, the lack of significant differences in clinical efficacy should not be used to justify frequent product changes on financial or nonclinical grounds because of the increased risk of adverse effects and difficulty in tracking a suspect product in the event of a future outbreak of IVIG-associated viral transmission.
authors.affiliation: Department of Clinical Immunology, Oxford University Hospitals NHS Trust, John Radcliffe Hospital, Oxford, United Kingdom.
authors.forename: Siraj A
authors.initials: SA
authors.lastname: Misbah
mesh_terms: D001327:Autoimmune Diseases / Q000188:drug therapy; D057915:Drug Substitution; D016568:Drugs, Generic / Q000627:therapeutic use*; D019317:Evidence-Based Medicine; D006801:Humans; D007074:Immunoglobulin G / Q000627:therapeutic use*; D016756:Immunoglobulins, Intravenous / Q000627:therapeutic use*; D007153:Immunologic Deficiency Syndromes / Q000188:drug therapy; D018579:Patient Selection; D012107:Research Design
chemical_list: D016568:Drugs, Generic; D007074:Immunoglobulin G; D016756:Immunoglobulins, Intravenous
keywords: Generic adverse effects; Immunoglobulin G; Intravenous immunoglobulin