Anwendung von Omalizumab-Biosimilars bei CRSwNP im deutschen Gesundheitssystem – ein Positionspapier von AeDA und DGHNO-KHC

Research output: Contribution to journalResearch articleContributedpeer-review

Contributors

  • L. Klimek - , Center for Rhinology and Allergology Wiesbaden (Author)
  • F. Bärhold - , Center for Rhinology and Allergology Wiesbaden (Author)
  • U. Förster-Ruhrmann - , Charité – Universitätsmedizin Berlin (Author)
  • F. Klimek - , Center for Rhinology and Allergology Wiesbaden (Author)
  • C. Rott - , Center for Rhinology and Allergology Wiesbaden (Author)
  • A. G. Beule - , University of Münster (Author)
  • A. Chaker - , Technical University of Munich (Author)
  • J. Hagemann - , Center for Rhinology and Allergology Wiesbaden (Author)
  • T. Huppertz - , University Medical Center Mainz (Author)
  • T. K. Hoffmann - , Ulm University (Author)
  • S. Dazert - , Catholic Hospital Bochum gGmbH (Author)
  • T. Deitmer - , German Society of Oto-Rhino-Laryngology, Head and Neck Surgery (Author)
  • H. Olze - , Charité – Universitätsmedizin Berlin (Author)
  • S. Strieth - , University of Bonn (Author)
  • H. Wrede - , ENT and Allergy Center Herford (Author)
  • W. Schlenter - , Medical Association of German Allergists (Author)
  • H. J. Welkoborsky - , Klinikum Region Hannover GmbH (Author)
  • B. Wollenberg - , Technical University of Munich (Author)
  • T. Albrecht - , University Hospital Tübingen (Author)
  • C. Rudack - , University of Münster (Author)
  • M. Wagenmann - , University Hospital Duesseldorf (Author)
  • Ch Bergmann - , Klinik RKM 740 (Author)
  • M. Cuevas - , Department of Otorhinolaryngology, Head and Neck Surgery, ENT Practice PD Dr. med. habil. M. Cuevas (Author)
  • B. Haxel - , Schwarzwald-Baar Hospital Villingen-Schwenningen (Author)
  • Ch St Betz - , University of Hamburg (Author)
  • A. S. Hoffmann - , University of Hamburg (Author)
  • C. Beutner - , University of Göttingen (Author)
  • O. Guntinas-Lichius - , Friedrich Schiller University Jena (Author)
  • M. Laudien - , University Hospital Schleswig-Holstein Campus Kiel (Author)
  • M. Gröger - , Ludwig Maximilian University of Munich (Author)
  • S. Becker - , University Hospital Tübingen (Author)

Abstract

Background Chronic rhinosinusitis with nasal polyps (CRSwNP) is a multifactorial inflammatory disease of the nasal and para-nasal mucosa, most often caused by TH2 inflammation. IgE antibodies play an important role in this disease. The anti-IgE antibody omalizumab was approved in August 2020 for the treatment of patients aged 18 years and older with severe CRSwNP as add-on therapy to intranasal corticosteroids (INCS) when adequate disease control cannot be achieved with INCS alone. Omlyclo, a biosimilar of Xolair containing the active ingredient omalizumab (CT-P39), was approved in the EU in May 2024. In Germany, Omlyclo has been officially available by prescription since September 15, 2025, and is available as 75 mg and 150 mg pre-filled syringes and pre-filled pens. An extension of the marketing authorization for the 300 mg dosage followed in November 2025. Methods A literature search was conducted to analyze the immunologyof CRSwNP and to identify the evidence for the efficacy of omalizumabin this disease through searches in Medline, PubMed, national and international study and guideline registries, and the Cochrane Library. Results Based on this information from the international literature, an expert panel from the Association of German Allergists and the German Society for Otorhinolaryngology and Head and Neck Surgery provides recommendations for the use of the omalizumab biosimilar CTP39 in CRSwNP within the German healthcare system. Conclusion The omalizumab biosimilar is approved for patients aged 18 years and older with severe chronic rhinosinusitis with nasal polyps as add-on therapy to intranasal corticosteroids when adequate disease control cannot be achieved with singel intranasal corticosteroids therapy. A documentation form has been developed to simplify the documentation of the indication.

Translated title of the contribution
Use of Omalizumab-biosimilars for CRSwNP in the German Health Care System – a Position Paper of the German Societies for Allergy AeDA and ORL DGHNO-KHC

Details

Original languageGerman
Pages (from-to)210-223
Number of pages14
JournalLaryngo- rhino- otologie
Volume105
Issue number4
Publication statusPublished - 1 Apr 2026
Peer-reviewedYes

External IDs

PubMed 41926944
ORCID /0009-0007-1117-2210/work/212492720

Keywords

ASJC Scopus subject areas

Keywords

  • Biologics, Chronic rhinosinusitis, CRSwNP, endotype classification, Omalizumab, Omlyclo, Xolair