{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,24]],"date-time":"2026-10-24T00:22:10Z","timestamp":1792801330989,"version":"4.5.0"},"reference-count":55,"publisher":"SAGE Publications","license":[{"start":{"date-parts":[[2020,1,1]],"date-time":"2020-01-01T00:00:00Z","timestamp":1577836800000},"content-version":"unspecified","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Biomark\ufffdInsights"],"published-print":{"date-parts":[[2020,1]]},"abstract":"<jats:p>Biomarkers are widely used at every stage of drug discovery and development. Utilisation of biomarkers has a potential to make drug discovery, development and approval processes more efficient. An overview of the current global regulatory landscape is presented in this article with particular emphasis on the validation and qualification of biomarkers, as well as legal framework for companion diagnostics. Furthermore, this article shows how the number of approved drugs with at least 1 biomarker used during development (biomarker acceptance) is affected by the recent advances in the biomarker regulations. More than half of analysed approvals were supported by biomarker data and there has been a slight increase in acceptance of biomarkers in recent years, even though the growth is not continuous. For certain pharmacotherapeutic groups, approvals with biomarkers are more common than without. Examples include immunosuppressants, immunostimulants, drugs used in diabetes, antithrombotic drugs, antineoplastic agents and antivirals. As a conclusion, potential benefits, challenges and opportunities of using biomarkers in drug discovery and development in the current regulatory landscape are summarised and discussed.<\/jats:p>","DOI":"10.1177\/1177271920974652","type":"journal-article","created":{"date-parts":[[2020,12,10]],"date-time":"2020-12-10T13:16:54Z","timestamp":1607606214000},"page":"117727192097465","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":95,"title":["Biomarkers: Opportunities and Challenges for Drug Development in the Current Regulatory Landscape"],"prefix":"10.1177","volume":"15","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-7602-7598","authenticated-orcid":false,"given":"Mariya","family":"Gromova","sequence":"first","affiliation":[{"name":"Biopharma Excellence GmbH, Munich, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Annegret","family":"Vaggelas","sequence":"additional","affiliation":[{"name":"Biopharma Excellence GmbH, Munich, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gabriele","family":"Dallmann","sequence":"additional","affiliation":[{"name":"Biopharma Excellence GmbH, Munich, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Diane","family":"Seimetz","sequence":"additional","affiliation":[{"name":"Biopharma Excellence GmbH, Munich, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"179","published-online":{"date-parts":[[2020,12,8]]},"reference":[{"key":"bibr1-1177271920974652","doi-asserted-by":"publisher","DOI":"10.4061\/2011\/164832"},{"key":"bibr2-1177271920974652","doi-asserted-by":"publisher","DOI":"10.1177\/003591577707001112"},{"key":"bibr3-1177271920974652","first-page":"1","volume-title":"Accelerating the Development of Biomarkers for Drug Safety: Workshop Summary","author":"Institute of Medicine (US) Forum on Drug Discovery Development and Translation. 1","year":"2009"},{"key":"bibr4-1177271920974652","doi-asserted-by":"publisher","DOI":"10.1007\/978-3-658-06382-5_7"},{"key":"bibr7-1177271920974652","doi-asserted-by":"publisher","DOI":"10.1177\/1535370217750088"},{"key":"bibr8-1177271920974652","doi-asserted-by":"publisher","DOI":"10.1016\/j.jpeds.2008.05.005"},{"key":"bibr9-1177271920974652","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa01133202"},{"key":"bibr10-1177271920974652","doi-asserted-by":"publisher","DOI":"10.1161\/01.cir.0000437738.63853.7a"},{"key":"bibr11-1177271920974652","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1105535"},{"key":"bibr12-1177271920974652","doi-asserted-by":"publisher","DOI":"10.1007\/s10689-015-9825-9"},{"key":"bibr13-1177271920974652","doi-asserted-by":"publisher","DOI":"10.1016\/j.cca.2014.08.039"},{"key":"bibr14-1177271920974652","doi-asserted-by":"publisher","DOI":"10.1093\/hmg\/3.4.569"},{"key":"bibr15-1177271920974652","doi-asserted-by":"publisher","DOI":"10.1001\/jama.282.8.790"},{"key":"bibr16-1177271920974652","first-page":"19","volume-title":"Pharmaceutical Medicine and Translational Clinical Research","volume":"2018","author":"Sinha S"},{"key":"bibr18-1177271920974652","doi-asserted-by":"publisher","DOI":"10.1038\/nrd1749"},{"key":"bibr19-1177271920974652","doi-asserted-by":"publisher","DOI":"10.1038\/nrd3931"},{"key":"bibr20-1177271920974652","volume-title":"Reflection Paper on Pharmacogenomic Samples, Testing and Data Handling","author":"EMA CHMP","year":"2006"},{"key":"bibr21-1177271920974652","volume-title":"Reflection Paper on Pharmacogenomics in Oncology","author":"EMA CHMP","year":"2008"},{"key":"bibr22-1177271920974652","volume-title":"Reflection Paper on Co-Development of Pharmacogenomic 4 Biomarkers and Assays in the Context of Drug 5 Development","author":"EMA CHMP","year":"2010"},{"key":"bibr23-1177271920974652","volume-title":"Guideline on the Use of Pharmacogenetic Methodologies in the Pharmacokinetic Evaluation of Medicinal Products","author":"EMA CHMP","year":"2011"},{"key":"bibr24-1177271920974652","volume-title":"Concept Paper on Good Genomics Biomarker Practices","author":"EMA CHMP","year":"2014"},{"key":"bibr25-1177271920974652","volume-title":"Guidance for Industry. 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