{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,21]],"date-time":"2026-04-21T13:53:21Z","timestamp":1776779601901,"version":"3.51.2"},"reference-count":27,"publisher":"Wiley","issue":"4","license":[{"start":{"date-parts":[[2025,7,24]],"date-time":"2025-07-24T00:00:00Z","timestamp":1753315200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["eJHaem"],"published-print":{"date-parts":[[2025,8]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Background<\/jats:title><jats:p>This was a randomized multicenter single\u2010blinded active\u2010controlled equivalence Phase III study evaluating the efficacy and safety of the biosimilar of romiplostim (GP40141) compared to the reference drug Nplate in patients with persistent or chronic immune thrombocytopenia (ITP).<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>The study included 136 adult patients randomized 1:1 to receive either the biosimilar or reference drug for 26 weeks. The primary endpoint was the proportion of patients achieving a platelet response (\u2265 50\u00a0\u00d7\u00a010<jats:sup>9<\/jats:sup>\/L) at Week 11. Key secondary endpoints included proportion of patients with durable platelet response, stable response in treatment\u2010naive patients, incidence of bleeding, and rescue therapy usage.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>The proportion of patients with platelet response after 10 weeks of therapy was 78% in the test group and 85% in the comparison group. The absolute difference in proportion between groups was \u22120.06 (95% CI [\u22120.196, 0.068] and it falls within the equivalence limits [\u22120.225, 0.225]). The study demonstrated equivalence in the primary endpoint, with no significant differences between the biosimilar and reference drug groups in durable responses rate, bleeding events, or safety profiles.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>The results support the biosimilar romiplostim as an equivalent and comparable treatment option to the reference drug for patients with persistent or chronic ITP.<\/jats:p><\/jats:sec><jats:sec><jats:title>Trial Registration<\/jats:title><jats:p>NCT06497036<\/jats:p><\/jats:sec>","DOI":"10.1002\/jha2.70105","type":"journal-article","created":{"date-parts":[[2025,7,24]],"date-time":"2025-07-24T14:25:06Z","timestamp":1753367106000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":2,"title":["Multicenter Single\u2010Blind Randomized Controlled Trial of the Romiplostim Biosimilar"],"prefix":"10.1002","volume":"6","author":[{"given":"Anait L.","family":"Melikyan","sequence":"first","affiliation":[{"name":"National Research Center for Hematology  Moscow Russian Federation"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4341-2884","authenticated-orcid":false,"given":"Ekaterina A.","family":"Protsenko","sequence":"additional","affiliation":[{"name":"R&amp;D Center GEROPHARM  St Petersburg Russian Federation"},{"name":"Public Health Sciences Department ITMO University  St Petersburg Russian Federation"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Galina N.","family":"Salogub","sequence":"additional","affiliation":[{"name":"Almazov National Medical Research Centre Ministry of Health of Russia  St Petersburg Russian Federation"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Bulat A.","family":"Bakirov","sequence":"additional","affiliation":[{"name":"Federal State Budgetary Educational Institution of Higher Education \u201cBashkir State Medical University of the Ministry of Healthcare of the Russian Federation,\u201d  Ufa Russian Federation"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Igor L.","family":"Davydkin","sequence":"additional","affiliation":[{"name":"Federal State Budgetary Educational Institution of Higher Education \u201cSamara State Medical University,\u201d  Samara Russian Federation"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Vladislav V.","family":"Kovalik","sequence":"additional","affiliation":[{"name":"R&amp;D Center GEROPHARM  St Petersburg Russian Federation"},{"name":"Public Health Sciences Department ITMO University  St Petersburg Russian Federation"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mariia L.","family":"Gefen","sequence":"additional","affiliation":[{"name":"R&amp;D Center GEROPHARM  St Petersburg Russian Federation"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yuliia D.","family":"Matvienko","sequence":"additional","affiliation":[{"name":"R&amp;D Center GEROPHARM  St Petersburg Russian Federation"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Valeria B.","family":"Saparova","sequence":"additional","affiliation":[{"name":"R&amp;D Center GEROPHARM  St Petersburg Russian Federation"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Alexander L.","family":"Khokhlov","sequence":"additional","affiliation":[{"name":"Federal State Budgetary Educational Institution of Higher Education \u201cYaroslavl State Medical University\u201d of the Ministry of Healthcare of the Russian Federation  Yaroslavl Russian Federation"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Igor E.","family":"Makarenko","sequence":"additional","affiliation":[{"name":"R&amp;D Center GEROPHARM  St Petersburg Russian Federation"},{"name":"Federal State Budgetary Scientific Institution Moscow State University of Medicine and Dentistry Named After V.I. 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