{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,14]],"date-time":"2026-09-14T12:14:41Z","timestamp":1789388081022,"version":"build-2803163510"},"reference-count":10,"publisher":"Wiley","issue":"1","license":[{"start":{"date-parts":[[2026,3,29]],"date-time":"2026-03-29T00:00:00Z","timestamp":1774742400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"},{"start":{"date-parts":[[2026,3,29]],"date-time":"2026-03-29T00:00:00Z","timestamp":1774742400000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"content-domain":{"domain":["aao-hnsfjournals.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Otolaryngol.--head neck surg."],"published-print":{"date-parts":[[2026,7]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:p>In March 2025, the Food and Drug Administration (FDA) approved the first respiratory biosimilar: omalizumab\u2010igec. FDA designated omalizumab\u2010igec as \u201cinterchangeable\u201d with the anti\u2010IgE antibody omalizumab, which will permit pharmacists to perform substitution without consulting providers. This biosimilar will compete with blockbuster biologics indicated for the treatment of chronic rhinosinusitis with nasal polyposis (CRSwNP) and other inflammatory airway diseases. Biologics are presently not cost\u2010effective for CRSwNP and should be reserved for patients who have not responded to conventional therapy (eg, nasal steroids and endoscopic sinus surgery) or are unfit for surgery. However, market entry of omalizumab\u2010igec and other omalizumab biosimilars in late\u2010stage clinical development may spur substantial price reductions if biosimilar manufacturers are able to overcome barriers such as patient and physician skepticism and restrictive state pharmacy laws (eg, requiring patient consent for biosimilar substitution). Comparative cost\u2010effectiveness research is necessary to inform coverage policies and treatment decisions by patients and clinicians.<\/jats:p>","DOI":"10.1002\/ohn.70227","type":"journal-article","created":{"date-parts":[[2026,3,29]],"date-time":"2026-03-29T19:49:11Z","timestamp":1774813751000},"page":"251-253","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["FDA Approval of Respiratory Biosimilars\u2014Turning the Tide of Cost\u2010Effectiveness?"],"prefix":"10.1002","volume":"175","author":[{"given":"Ashley L.","family":"Miller","sequence":"first","affiliation":[{"name":"Department of Otolaryngology Nationwide Children's Hospital Columbus Ohio USA"},{"name":"Department of Otolaryngology\u2013Head &amp; Neck Surgery The Ohio State University College of Medicine Columbus Ohio USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Charles A.","family":"Elmaraghy","sequence":"additional","affiliation":[{"name":"Department of Otolaryngology Nationwide Children's Hospital Columbus Ohio USA"},{"name":"Department of Otolaryngology\u2013Head &amp; Neck Surgery The Ohio State University College of Medicine Columbus Ohio USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Casey D.","family":"Curtis","sequence":"additional","affiliation":[{"name":"Department of Otolaryngology\u2013Head &amp; Neck Surgery The Ohio State University College of Medicine Columbus Ohio USA"},{"name":"Department of Otolaryngology\u2010Head &amp; Neck Surgery, Division of Allergy and Immunology The Ohio State University College of Medicine Columbus Ohio USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Vinay K.","family":"Rathi","sequence":"additional","affiliation":[{"name":"Department of Otolaryngology\u2013Head &amp; Neck Surgery The Ohio State University College of Medicine Columbus Ohio USA"},{"name":"The Center for the Advancement of Team Science, Analytics, and Systems Thinking in Health Services and Implementation Science Research (CATALYST) The Ohio State University College of Medicine Columbus Ohio USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2026,3,29]]},"reference":[{"key":"e_1_2_8_2_1","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2024.16911"},{"key":"e_1_2_8_3_1","doi-asserted-by":"publisher","DOI":"10.1002\/alr.23185"},{"key":"e_1_2_8_4_1","unstructured":"MongeA ThaiL.Competition in the U.S. Therapeutic Biologics Market. Department of Health and Human Services Assistant Secretary for Planning and Evaluation; 2025. Accessed November 17 2025.https:\/\/aspe.hhs.gov\/sites\/default\/files\/documents\/3a05af053eeeaa4c7c95457dcafefa68\/ASPE-Competition-in-the-Biologics-Market.pdf"},{"key":"e_1_2_8_5_1","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2024.15225"},{"key":"e_1_2_8_6_1","unstructured":"Eastern Research Group.U.S. Biosimilar Market Entry Challenges and Facilitating Factors: Final Report. 2025. Accessed November 17 2025.https:\/\/aspe.hhs.gov\/sites\/default\/files\/documents\/2d5c0a194c180b52d1c760d3bb09f70a\/Biosimilars%20Final%20Report_250825_v508.pdf"},{"key":"e_1_2_8_7_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jval.2025.02.008"},{"key":"e_1_2_8_8_1","doi-asserted-by":"publisher","DOI":"10.1002\/alr.70109"},{"issue":"25","key":"e_1_2_8_9_1","article-title":"Dupilumab versus omalizumab in patients with chronic rhinosinusitis with nasal polyps and coexisting asthma (EVEREST): a multicentre, randomised, double\u2010blind, head\u2010to\u2010head phase 4 trial","volume":"2213","author":"De Corso E","year":"2025","journal-title":"Lancet Respir Med"},{"issue":"3","key":"e_1_2_8_10_1","first-page":"194","article-title":"EPOS\/EUFOREA update on indication and evaluation of Biologics in Chronic Rhinosinusitis with Nasal Polyps 2023","volume":"61","author":"Fokkens WJ","year":"2023","journal-title":"Rhinology"},{"key":"e_1_2_8_11_1","unstructured":"TiceJA WalshJME SynnottP et al.Biologic Therapies for Treatment of Asthma Associated with Type 2 Inflammation: Effectiveness Value and Value\u2010Based Price Benchmarks. Institute for Clinical and Economic Review; 2018. Accessed September 23 2025.https:\/\/icer.org\/wp-content\/uploads\/2020\/10\/ICER_Asthma-Final-Report_Unredacted_08122020.pdf"}],"container-title":["Otolaryngology\u2013Head and Neck Surgery"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/aao-hnsfjournals.onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/ohn.70227","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/aao-hnsfjournals.onlinelibrary.wiley.com\/doi\/full-xml\/10.1002\/ohn.70227","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/aao-hnsfjournals.onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/ohn.70227","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,7,2]],"date-time":"2026-07-02T18:06:07Z","timestamp":1783015567000},"score":1,"resource":{"primary":{"URL":"https:\/\/aao-hnsfjournals.onlinelibrary.wiley.com\/doi\/10.1002\/ohn.70227"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,3,29]]},"references-count":10,"journal-issue":{"issue":"1","published-print":{"date-parts":[[2026,7]]}},"alternative-id":["10.1002\/ohn.70227"],"URL":"https:\/\/doi.org\/10.1002\/ohn.70227","archive":["Portico"],"relation":{},"ISSN":["0194-5998","1097-6817"],"issn-type":[{"value":"0194-5998","type":"print"},{"value":"1097-6817","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,3,29]]},"assertion":[{"value":"2025-11-29","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2026-03-16","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2026-03-29","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}