[Evolution of biologicals in inflammation medicine--biosimilars in gastroenterology, rheumatology and dermatology].
Biologicals revolutionized the therapy of chronic inflammatory diseases in gastroenterology, rheumatology and dermatology in the last decade. The first generation biologicals mainly targeted against the pro-inflammatory cytokine TNF-α. The evolution of these therapies in the last years led to the development of new antibodies and to the admission of first generation "generic" biologics - the biosimilars. Biosimilars are not a fundamental new pharmacological development for existing substances, however they have the potential to lead to enormous cost savings in healthcare without reducing the level of care for patients. Biosimilars are not identical with the originator, but in an extensive biosimilarity exercise including analytical, preclinical and comparative clinical studies it was shown that the biosimilars could demonstrate comparability in all relevant aspects with the originator.In September 2013, the Infliximab biosimilars (Inflectra(®), Remsina(®)) were the first biosimilars for monoclonal antibodies to be authorized by the EMA for use in the European Union. By demonstrating the therapeutic similarity only in one indication (rheumatoid arthritis) the EMA agreed with an extrapolation also to all approved indications of the originator. This could be a relevant problem in clinical practice. Therefore, comparative studies with the originator are required in all approved indications.After expiration of the national patent protection in beginning of 2015, the infliximab biosimilars will be launched on the market in Germany and will be part of the therapeutic arsenal in gastroenterology, rheumatology and dermatology. Interchangeability (Switching) of biosimilars with the originator will be subject of an important discussion with the health care providers. Regardless of the biosimilars EMA-approval, several potential problems (efficacy, extrapolation, switching, long-term safety) should be the topic of intensive long-term registries in the future.
Klinik für Innere Medizin I, Universitätsklinikum Schleswig-Holstein, Campus Kiel.
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Schreiber
Klinik für Hautkrankheiten, Universitätsklinikum Münster.
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T
Luger
Herescon GmbH, Hannover.
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Mittendorf
Psoriasis Zentrum, Universitäts-Hautklinik Kiel.
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Mrowietz
Abteilung für Rheumatologie und klinische Immunologie der Kerckhoff Klinik, Bad Nauheim.
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Müller-Ladner
Klinik für Innere Medizin I, Universitätsklinikum Schleswig-Holstein, Campus Kiel.
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Schröder
Klinik für Innere Medizin IV, Universitätsklinikum Jena.
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Stallmach
Klinik für Innere Medizin I, Universitätsklinikum Schleswig-Holstein, Campus Kiel.
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B
Bokemeyer
D000911:Antibodies, Monoclonal / Q000009:adverse effects / Q000191:economics / Q000627:therapeutic use; D001172:Arthritis, Rheumatoid / Q000188:drug therapy / Q000191:economics / Q000276:immunology; D001688:Biological Products / Q000009:adverse effects / Q000191:economics / Q000627:therapeutic use*; D059451:Biosimilar Pharmaceuticals / Q000009:adverse effects / Q000191:economics / Q000627:therapeutic use*; D017046:Cost Savings; D017277:Drug Approval; D005062:European Union; D005767:Gastrointestinal Diseases / Q000188:drug therapy* / Q000191:economics / Q000276:immunology; D005858:Germany; D006801:Humans; D007249:Inflammation / Q000188:drug therapy / Q000191:economics / Q000276:immunology; D000069285:Infliximab; D009313:National Health Programs / Q000191:economics; D010330:Patents as Topic; D012216:Rheumatic Diseases / Q000188:drug therapy* / Q000191:economics / Q000276:immunology; D012871:Skin Diseases / Q000188:drug therapy* / Q000191:economics / Q000276:immunology; D013810:Therapeutic Equivalency; D014409:Tumor Necrosis Factor-alpha / Q000037:antagonists & inhibitors
D000911:Antibodies, Monoclonal; D001688:Biological Products; D059451:Biosimilar Pharmaceuticals; C000591237:CT-P13; C439524:TNF protein, human; D014409:Tumor Necrosis Factor-alpha; D000069285:Infliximab