{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,25]],"date-time":"2026-08-25T13:20:08Z","timestamp":1787664008196,"version":"build-2736575974"},"reference-count":20,"publisher":"Wiley","issue":"8","license":[{"start":{"date-parts":[[2026,8,9]],"date-time":"2026-08-09T00:00:00Z","timestamp":1786233600000},"content-version":"vor","delay-in-days":8,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"},{"start":{"date-parts":[[2026,8,1]],"date-time":"2026-08-01T00:00:00Z","timestamp":1785542400000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"content-domain":{"domain":["accp1.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["The Journal of Clinical Pharma"],"published-print":{"date-parts":[[2026,8]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:p>The development and approval of biosimilars are imperative for improving patient access to safe and effective treatments. This article summarizes the regulatory approval for Tyruko, the first FDA\u2010approved biosimilar for natalizumab for the treatment of multiple sclerosis and Crohn's disease. Biosimilarity between the proposed biosimilar and the reference product was demonstrated through a comprehensive comparative assessment that included structural and functional characterization, pharmacokinetics (PK)\/pharmacodynamics (PD) data, immunogenicity, and safety. The PD assessment incorporated a panel of biomarkers indicative of target engagement and downstream biological responses. The current case underscores the importance of the 351(k) pathway and highlights how the PD\u2010based approach, in conjunction with comparative analytical assessments and PK data, supported the approval of the biosimilar through a study design relying on fewer subjects and a shorter duration compared to an efficacy study.<\/jats:p>","DOI":"10.1002\/jcph.70257","type":"journal-article","created":{"date-parts":[[2026,8,10]],"date-time":"2026-08-10T04:50:45Z","timestamp":1786337445000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["FDA's Approval Summary of the First Biosimilar to Natalizumab for the Treatment of Multiple Sclerosis and Crohn's Disease"],"prefix":"10.1002","volume":"66","author":[{"ORCID":"https:\/\/orcid.org\/0009-0006-0646-8087","authenticated-orcid":false,"given":"Poonam R.","family":"Delvadia","sequence":"first","affiliation":[{"name":"Division of Neuropsychiatric Pharmacology Office of Clinical Pharmacology Office of Translational Sciences Center for Drug Evaluation and Research Food and Drug Administration  Silver Spring MD USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anantha Ram","family":"Nookala","sequence":"additional","affiliation":[{"name":"Division of Neuropsychiatric Pharmacology Office of Clinical Pharmacology Office of Translational Sciences Center for Drug Evaluation and Research Food and Drug Administration  Silver Spring MD USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gopichand","family":"Gottipati","sequence":"additional","affiliation":[{"name":"Division of Neuropsychiatric Pharmacology Office of Clinical Pharmacology Office of Translational Sciences Center for Drug Evaluation and Research Food and Drug Administration  Silver Spring MD 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Neuroscience Office of New Drugs Center for Drug Evaluation and Research Food and Drug Administration  Silver Spring MD USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1795-1542","authenticated-orcid":false,"given":"Laura","family":"Baldassari","sequence":"additional","affiliation":[{"name":"Division of Neurology II Office of Neuroscience Office of New Drugs Center for Drug Evaluation and Research Food and Drug Administration  Silver Spring MD USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6681-562X","authenticated-orcid":false,"given":"Paul","family":"Lee","sequence":"additional","affiliation":[{"name":"Division of Neurology II Office of Neuroscience Office of New Drugs Center for Drug Evaluation and Research Food and Drug Administration  Silver Spring MD USA"},{"name":"Clintrex Research LLC A BlueRidge Life Sciences Company  Houston TX 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