{"title":"2024年胃肠病学和肝脏病学的药物批准","authors":"Eleni Kotsiliti","doi":"10.1038/s41575-025-01036-0","DOIUrl":null,"url":null,"abstract":"<p>2024 saw the approvals of several drugs by the FDA and the EMA related to gastroenterology and hepatology.</p><p>In 2024, the FDA also approved biosimilar products to Stelara (Janssen; ustekinumab, a monoclonal antibody targeting IL-12 and IL-23) for the treatment of moderate to severely active Crohn’s disease and ulcerative colitis, which included Steqeyma (Celltrion), Yesintek (Biocon Biologics), Imuldosa (Janssen), Otulfi (Fresenius Kabi and Formycon) and Pyzchiva (Sandoz). For the treatment of moderate to severely active Crohn’s disease in adults and paediatric patients >6 years of age and of moderately to severely active ulcerative colitis in adult patients, the FDA approved the biosimilar to Humira (AbbVie; adalimumab, a monoclonal antibody targeting TNF), Simlandi (Telva and Alvotech). For treating HER2-overexpressing metastatic gastric or gastro-oesophageal junction adenocarcinoma, the FDA approved Hercessi (Accord), a biosimilar to Herceptin (Genentech; trastuzumab, a monoclonal antibody that binds HER2 receptors).</p>","PeriodicalId":18793,"journal":{"name":"Nature Reviews Gastroenterology &Hepatology","volume":"68 1","pages":""},"PeriodicalIF":45.9000,"publicationDate":"2025-01-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Drug approvals in gastroenterology and hepatology in 2024\",\"authors\":\"Eleni Kotsiliti\",\"doi\":\"10.1038/s41575-025-01036-0\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p>2024 saw the approvals of several drugs by the FDA and the EMA related to gastroenterology and hepatology.</p><p>In 2024, the FDA also approved biosimilar products to Stelara (Janssen; ustekinumab, a monoclonal antibody targeting IL-12 and IL-23) for the treatment of moderate to severely active Crohn’s disease and ulcerative colitis, which included Steqeyma (Celltrion), Yesintek (Biocon Biologics), Imuldosa (Janssen), Otulfi (Fresenius Kabi and Formycon) and Pyzchiva (Sandoz). For the treatment of moderate to severely active Crohn’s disease in adults and paediatric patients >6 years of age and of moderately to severely active ulcerative colitis in adult patients, the FDA approved the biosimilar to Humira (AbbVie; adalimumab, a monoclonal antibody targeting TNF), Simlandi (Telva and Alvotech). For treating HER2-overexpressing metastatic gastric or gastro-oesophageal junction adenocarcinoma, the FDA approved Hercessi (Accord), a biosimilar to Herceptin (Genentech; trastuzumab, a monoclonal antibody that binds HER2 receptors).</p>\",\"PeriodicalId\":18793,\"journal\":{\"name\":\"Nature Reviews Gastroenterology &Hepatology\",\"volume\":\"68 1\",\"pages\":\"\"},\"PeriodicalIF\":45.9000,\"publicationDate\":\"2025-01-13\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Nature Reviews Gastroenterology &Hepatology\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1038/s41575-025-01036-0\",\"RegionNum\":1,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"GASTROENTEROLOGY & HEPATOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Nature Reviews Gastroenterology &Hepatology","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1038/s41575-025-01036-0","RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"GASTROENTEROLOGY & HEPATOLOGY","Score":null,"Total":0}
Drug approvals in gastroenterology and hepatology in 2024
2024 saw the approvals of several drugs by the FDA and the EMA related to gastroenterology and hepatology.
In 2024, the FDA also approved biosimilar products to Stelara (Janssen; ustekinumab, a monoclonal antibody targeting IL-12 and IL-23) for the treatment of moderate to severely active Crohn’s disease and ulcerative colitis, which included Steqeyma (Celltrion), Yesintek (Biocon Biologics), Imuldosa (Janssen), Otulfi (Fresenius Kabi and Formycon) and Pyzchiva (Sandoz). For the treatment of moderate to severely active Crohn’s disease in adults and paediatric patients >6 years of age and of moderately to severely active ulcerative colitis in adult patients, the FDA approved the biosimilar to Humira (AbbVie; adalimumab, a monoclonal antibody targeting TNF), Simlandi (Telva and Alvotech). For treating HER2-overexpressing metastatic gastric or gastro-oesophageal junction adenocarcinoma, the FDA approved Hercessi (Accord), a biosimilar to Herceptin (Genentech; trastuzumab, a monoclonal antibody that binds HER2 receptors).
期刊介绍：
Nature Reviews Gastroenterology & Hepatology aims to serve as the leading resource for Reviews and commentaries within the scientific and medical communities it caters to. The journal strives to maintain authority, accessibility, and clarity in its published articles, which are complemented by easily understandable figures, tables, and other display items. Dedicated to providing exceptional service to authors, referees, and readers, the editorial team works diligently to maximize the usefulness and impact of each publication.
The journal encompasses a wide range of content types, including Research Highlights, News & Views, Comments, Reviews, Perspectives, and Consensus Statements, all pertinent to gastroenterologists and hepatologists. With its broad scope, Nature Reviews Gastroenterology & Hepatology ensures that its articles reach a diverse audience, aiming for the widest possible dissemination of valuable information.
Nature Reviews Gastroenterology & Hepatology is part of the Nature Reviews portfolio of journals.
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