{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,12,31]],"date-time":"2025-12-31T07:42:28Z","timestamp":1767166948871,"version":"build-2238731810"},"reference-count":32,"publisher":"Elsevier BV","issue":"6","license":[{"start":{"date-parts":[[2018,1,1]],"date-time":"2018-01-01T00:00:00Z","timestamp":1514764800000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.elsevier.com\/tdm\/userlicense\/1.0\/"},{"start":{"date-parts":[[2020,10,22]],"date-time":"2020-10-22T00:00:00Z","timestamp":1603324800000},"content-version":"vor","delay-in-days":1025,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0"}],"content-domain":{"domain":["esmoopen.com","elsevier.com","sciencedirect.com"],"crossmark-restriction":true},"short-container-title":["ESMO Open"],"published-print":{"date-parts":[[2018]]},"DOI":"10.1136\/esmoopen-2018-000420","type":"journal-article","created":{"date-parts":[[2018,9,5]],"date-time":"2018-09-05T09:17:00Z","timestamp":1536139020000},"page":"e000420","update-policy":"https:\/\/doi.org\/10.1016\/elsevier_cm_policy","source":"Crossref","is-referenced-by-count":7,"title":["Preparing for the incoming wave of biosimilars in oncology"],"prefix":"10.1016","volume":"3","author":[{"given":"Elena","family":"Wolff-Holz","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Juan","family":"Garcia Burgos","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Rosa","family":"Giuliani","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Gustaf","family":"Befrits","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Johan","family":"de Munter","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Luisa","family":"Avedano","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Murray","family":"Aitken","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Rosa","family":"Gonzalez-Quevedo","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Malvika","family":"Vyas","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Elisabeth G.E.","family":"de Vries","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Josep","family":"Tabernero","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"78","reference":[{"key":"10.1136\/esmoopen-2018-000420_bb0010","unstructured":"European Medicines Agency. 2017. European public assessment reports. http:\/\/www.ema.europa.eu\/ema\/index.jsp?curl=pages%2Fmedicines%2Flanding%2Fepar_search.jsp&mid=WC0b01ac058001d124&searchTab=searchByAuthType&alreadyLoaded=true&isNewQuery=true&status=Authorised&keyword=Enter+keywords&searchType=name&taxonomyPath=&treeNumber=&searchGenericType=biosimilars&genericsKeywordSearch=Submit (accessed Nov 2017)."},{"key":"10.1136\/esmoopen-2018-000420_bb0015","doi-asserted-by":"crossref","DOI":"10.1136\/esmoopen-2016-000142","article-title":"Biosimilars: a position paper of the European Society for Medical Oncology, with particular reference to oncology prescribers","volume":"1","author":"Tabernero","year":"2016","journal-title":"ESMO Open"},{"key":"10.1136\/esmoopen-2018-000420_bb0020","author":"European Medicines Agency","year":"2014","journal-title":"Guideline on similar biological medicinal products. CHMP\/437\/04 Rev 1"},{"key":"10.1136\/esmoopen-2018-000420_bb0025","doi-asserted-by":"crossref","first-page":"363","DOI":"10.1007\/s40259-014-0088-z","article-title":"Drift, evolution, and divergence in biologics and biosimilars manufacturing","volume":"28","author":"Ramanan","year":"2014","journal-title":"BioDrugs"},{"key":"10.1136\/esmoopen-2018-000420_bb0030","doi-asserted-by":"crossref","first-page":"829","DOI":"10.1185\/03007995.2016.1145579","article-title":"Authorized manufacturing changes for therapeutic monoclonal antibodies (mAbs) in European Public Assessment Report (EPAR) documents","volume":"32","author":"Vez\u00e9r","year":"2016","journal-title":"Curr Med Res Opin"},{"key":"10.1136\/esmoopen-2018-000420_bb0035","unstructured":"Global oncology trends. 2017. Advances, complexity, and costs. IQVIA Institute for Human Data Science. https:\/\/www.iqvia.com\/institute\/reports\/global-oncology-trends-2017-advances-complexity-and-cost (accessed Mar 2018)."},{"key":"10.1136\/esmoopen-2018-000420_bb0040","series-title":"Oncology impact of biosimilars on the sustainability of healthcare systems European Society of medical Oncology Annual Conference Madrid Spain","author":"Aitken","year":"2017"},{"key":"10.1136\/esmoopen-2018-000420_bb0045","doi-asserted-by":"crossref","first-page":"83","DOI":"10.1007\/s40259-017-0210-0","article-title":"Interchangeability of Biosimilars: a European perspective","volume":"31","author":"Kurki","year":"2017","journal-title":"BioDrugs"},{"key":"10.1136\/esmoopen-2018-000420_bb0050","doi-asserted-by":"crossref","DOI":"10.1007\/s11926-017-0658-4","article-title":"Switching between reference biologics and biosimilars for the treatment of rheumatology, gastroenterology, and dermatology inflammatory conditions: considerations for the clinician","volume":"19","author":"Moots","year":"2017","journal-title":"Curr Rheumatol Rep"},{"key":"10.1136\/esmoopen-2018-000420_bb0055","doi-asserted-by":"crossref","first-page":"1548","DOI":"10.1016\/j.crohns.2014.06.007","article-title":"Viewpoint: knowledge and viewpoints on biosimilar monoclonal antibodies among members of the European Crohn\u2019s and Colitis Organization","volume":"8","author":"Danese","year":"2014","journal-title":"J Crohns Colitis"},{"key":"10.1136\/esmoopen-2018-000420_bb0060","doi-asserted-by":"crossref","first-page":"58","DOI":"10.5639\/gabij.2014.0302.018","article-title":"Biosimilars naming, label transparency and authority of choice \u2013 survey findings among European physicians","volume":"3","author":"Dolinar","year":"2014","journal-title":"Generics and Biosimilars Initiative Journal"},{"issue":"Suppl 4","key":"10.1136\/esmoopen-2018-000420_bb0065","doi-asserted-by":"crossref","first-page":"S1","DOI":"10.6004\/jnccn.2011.0136","article-title":"NCCN Biosimilars White Paper: regulatory, scientific, and patient safety perspectives","volume":"9","author":"Zelenetz","year":"2011","journal-title":"J Natl Compr Canc Netw"},{"key":"10.1136\/esmoopen-2018-000420_bb0070","doi-asserted-by":"crossref","first-page":"1362","DOI":"10.1093\/ecco-jcc\/jjw090","article-title":"Changes in biosimilar knowledge among European Crohn\u2019s Colitis Organization [ECCO] Members: An Updated Survey","volume":"10","author":"Danese","year":"2016","journal-title":"J Crohns Colitis"},{"key":"10.1136\/esmoopen-2018-000420_bb0075","doi-asserted-by":"crossref","first-page":"1605","DOI":"10.1136\/annrheumdis-2012-203091","article-title":"A randomised, double-blind, multicentre, parallel-group, prospective study comparing the pharmacokinetics, safety, and efficacy of CT-P13 and innovator infliximab in patients with ankylosing spondylitis: the PLANETAS study","volume":"72","author":"Park","year":"2013","journal-title":"Ann Rheum Dis"},{"key":"10.1136\/esmoopen-2018-000420_bb0080","doi-asserted-by":"crossref","first-page":"E87","DOI":"10.1002\/lary.24360","article-title":"Cisplatin otoprotection using transtympanic L-N-acetylcysteine: a pilot randomized study in head and neck cancer patients","volume":"124","author":"Yoo","year":"2014","journal-title":"Laryngoscope"},{"key":"10.1136\/esmoopen-2018-000420_bb0085","doi-asserted-by":"crossref","first-page":"1685","DOI":"10.1016\/j.cgh.2016.05.023","article-title":"Biosimilars in inflammatory bowel disease: facts and fears of extrapolation","volume":"14","author":"Ben-Horin","year":"2016","journal-title":"Clin Gastroenterol Hepatol"},{"key":"10.1136\/esmoopen-2018-000420_bb0090","doi-asserted-by":"crossref","first-page":"586","DOI":"10.1016\/j.crohns.2013.03.011","article-title":"Governing Board and Operational Board of ECCO. ECCO position statement: the use of biosimilar medicines in the treatment of inflammatory bowel disease (IBD)","volume":"7","author":"Danese","year":"2013","journal-title":"J Crohns Colitis"},{"key":"10.1136\/esmoopen-2018-000420_bb0095","unstructured":"European Medicines Agency. 2016. EPAR truxima. EMA\/CHMP\/75695\/2017. http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/EPAR_-_Public_assessment_report\/human\/004112\/WC500222695.pdf"},{"key":"10.1136\/esmoopen-2018-000420_bb0100","doi-asserted-by":"crossref","first-page":"128","DOI":"10.1093\/ecco-jcc\/jjw138","article-title":"Patient perspectives on biosimilars: a survey by the European Federation of Crohn\u2019s and Ulcerative Colitis Associations","volume":"11","author":"Peyrin-Biroulet","year":"2017","journal-title":"J Crohns Colitis"},{"key":"10.1136\/esmoopen-2018-000420_bb0105","unstructured":"Global Alliance for Patient Access (GAfPA). 2016.Patient advocacy and safety conference. Brussels, Belgiumhttp:\/\/www.efcca.org\/sites\/default\/files\/EFCCA-GAfPA-EU-Parliament-Report_0.pdf.CHMP\/437\/04."},{"key":"10.1136\/esmoopen-2018-000420_bb0110","unstructured":"European Medicines Agency and the European Commission. 2017.Biosimilars in the EU. Information Guide for Healthcare Professionals in Aprilhttp:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/Leaflet\/2017\/05\/WC500226648.pdf (accessed Nov 2017)."},{"key":"10.1136\/esmoopen-2018-000420_bb0115","author":"European Medicines Agency","year":"2009","journal-title":"Proposal for a revision of the European commission guideline on Summary of Product Characteristics. Overview of comments received on draft revision 2 of the SMPC guideline. EMEA\/CHMP\/663087\/2009"},{"key":"10.1136\/esmoopen-2018-000420_bb0120","author":"European Medicines Agency","year":"2012","journal-title":"QRD general principles regarding the SmPC information for a generic\/hybrid\/biosimilar product. EMA\/627621\/2011"},{"key":"10.1136\/esmoopen-2018-000420_bb0125","doi-asserted-by":"crossref","first-page":"221","DOI":"10.1111\/j.1742-7843.2011.00684.x","article-title":"The \u2018wise list\u2019- a comprehensive model for drug and therapeutics committees to achieve adherence to recommendations for essential drugs among prescribers?","volume":"108","author":"Stichele","year":"2011","journal-title":"Basic Clin Pharmacol Toxicol"},{"key":"10.1136\/esmoopen-2018-000420_bb0130","doi-asserted-by":"crossref","first-page":"26","DOI":"10.1093\/ecco-jcc\/jjw198","article-title":"ECCO position statement on the use of biosimilars for inflammatory bowel disease-an update","volume":"11","author":"Danese","year":"2017","journal-title":"J Crohns Colitis"},{"key":"10.1136\/esmoopen-2018-000420_bb0135","unstructured":"European Commission. 2016. What I need to know about biosimilar medicines. Information for Patients. http:\/\/ec.europa.eu\/DocsRoom\/documents\/20961 (accessed Mar 2018)."},{"key":"10.1136\/esmoopen-2018-000420_bb0140","doi-asserted-by":"crossref","DOI":"10.1136\/esmoopen-2017-000281","article-title":"Reply to \u2018Biosimilars: a position paper of the European Society for Medical Oncology, with particular reference to oncology prescribers","volume":"2","author":"Bakalos","year":"2017","journal-title":"ESMO Open"},{"key":"10.1136\/esmoopen-2018-000420_bb0145","doi-asserted-by":"crossref","first-page":"2304","DOI":"10.1016\/S0140-6736(17)30068-5","article-title":"Switching from originator infliximab to biosimilar CT-P13 compared with maintained treatment with originator infliximab (NOR-SWITCH): a 52-week, randomised, double-blind, non-inferiority trial;","volume":"389","author":"J\u00f8rgensen","year":"2017","journal-title":"Lancet"},{"issue":"supplement_1","key":"10.1136\/esmoopen-2018-000420_bb0150","doi-asserted-by":"crossref","first-page":"S348","DOI":"10.1093\/ecco-jcc\/jjx180.610","article-title":"P483 Long-term efficacy and safety of biosimilar infliximab (CT-P13) after switching from originator infliximab: Explorative subgroup analyses in IBD from the NOR-SWITCH EXTENSION trial","volume":"12","author":"J\u00f8rgensen","year":"2018","journal-title":"Journal of Crohn\u2019s and Colitis"},{"key":"10.1136\/esmoopen-2018-000420_bb0155","author":"European Medicines Agency","year":"2014","journal-title":"Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues. EMEA\/CHMP\/BMWP\/42832\/2005 Rev 1"},{"key":"10.1136\/esmoopen-2018-000420_bb0160","author":"European Medicines Agency","year":"2014","journal-title":"Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: quality issues (revision 1). EMA\/CHMP\/BWP\/247713\/2012"},{"key":"10.1136\/esmoopen-2018-000420_bb0165","unstructured":"European Medicines Agency. 2013. Concept paper on extrapolation of efficacy and safety in medicine development. EMA\/129698\/2012. http:\/\/www.ema.europa.eu\/ema\/index.jsp?curl=pages\/regulation\/general\/general_content_001219.jsp&mid= (accessed Mar 2018)."}],"updated-by":[{"DOI":"10.1136\/esmoopen-2018-000420corr1","type":"erratum","label":"Erratum","source":"publisher","updated":{"date-parts":[[2018,1,1]],"date-time":"2018-01-01T00:00:00Z","timestamp":1514764800000}}],"container-title":["ESMO Open"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.elsevier.com\/content\/article\/PII:S2059702920302155?httpAccept=text\/xml","content-type":"text\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/api.elsevier.com\/content\/article\/PII:S2059702920302155?httpAccept=text\/plain","content-type":"text\/plain","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/syndication.highwire.org\/content\/doi\/10.1136\/esmoopen-2018-000420","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2021,6,12]],"date-time":"2021-06-12T18:07:46Z","timestamp":1623521266000},"score":1,"resource":{"primary":{"URL":"https:\/\/linkinghub.elsevier.com\/retrieve\/pii\/S2059702920302155"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2018]]},"references-count":32,"journal-issue":{"issue":"6","published-print":{"date-parts":[[2018]]}},"alternative-id":["S2059702920302155"],"URL":"https:\/\/doi.org\/10.1136\/esmoopen-2018-000420","relation":{},"ISSN":["2059-7029"],"issn-type":[{"value":"2059-7029","type":"print"}],"subject":[],"published":{"date-parts":[[2018]]},"assertion":[{"value":"Elsevier","name":"publisher","label":"This article is maintained by"},{"value":"Preparing for the incoming wave of biosimilars in oncology","name":"articletitle","label":"Article Title"},{"value":"ESMO Open","name":"journaltitle","label":"Journal Title"},{"value":"https:\/\/doi.org\/10.1136\/esmoopen-2018-000420","name":"articlelink","label":"CrossRef DOI link to publisher maintained version"},{"value":"article","name":"content_type","label":"Content Type"},{"value":"\u00a9 2018 THE AUTHORS. Published by Elsevier Limited on behalf of European Society for Medical Oncology; Originally published by BMJ.","name":"copyright","label":"Copyright"}],"article-number":"e000420"}}