{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,2,19]],"date-time":"2026-02-19T07:21:29Z","timestamp":1771485689710,"version":"3.50.1"},"reference-count":37,"publisher":"Springer Science and Business Media LLC","issue":"12","license":[{"start":{"date-parts":[[2016,10,12]],"date-time":"2016-10-12T00:00:00Z","timestamp":1476230400000},"content-version":"unspecified","delay-in-days":0,"URL":"http:\/\/www.springer.com\/tdm"}],"funder":[{"DOI":"10.13039\/100004319","name":"Pfizer","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100004319","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Clin Rheumatol"],"published-print":{"date-parts":[[2016,12]]},"DOI":"10.1007\/s10067-016-3427-2","type":"journal-article","created":{"date-parts":[[2016,10,12]],"date-time":"2016-10-12T17:44:11Z","timestamp":1476294251000},"page":"2877-2886","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":29,"title":["Differentiating biosimilarity and comparability in biotherapeutics"],"prefix":"10.1007","volume":"35","author":[{"given":"Valderilio","family":"Azevedo","sequence":"first","affiliation":[]},{"given":"Brian","family":"Hassett","sequence":"additional","affiliation":[]},{"given":"Jo\u00e3o Eurico","family":"Fonseca","sequence":"additional","affiliation":[]},{"given":"Tatsuya","family":"Atsumi","sequence":"additional","affiliation":[]},{"given":"Javier","family":"Coindreau","sequence":"additional","affiliation":[]},{"given":"Ira","family":"Jacobs","sequence":"additional","affiliation":[]},{"given":"Ehab","family":"Mahgoub","sequence":"additional","affiliation":[]},{"given":"Julie","family":"O\u2019Brien","sequence":"additional","affiliation":[]},{"given":"Ena","family":"Singh","sequence":"additional","affiliation":[]},{"given":"Steven","family":"Vicik","sequence":"additional","affiliation":[]},{"given":"Brian","family":"Fitzpatrick","sequence":"additional","affiliation":[]}],"member":"297","published-online":{"date-parts":[[2016,10,12]]},"reference":[{"key":"3427_CR1","first-page":"24","volume":"1","author":"T Morrow","year":"2004","unstructured":"Morrow T, Felcone LH (2004) Defining the difference: what makes biologics unique. Biotechnol Healthc 1:24\u201329","journal-title":"Biotechnol Healthc"},{"issue":"Suppl 5","key":"3427_CR2","doi-asserted-by":"publisher","first-page":"v4","DOI":"10.1093\/ndt\/gfl474","volume":"21","author":"M Kuhlmann","year":"2006","unstructured":"Kuhlmann M, Covic A (2006) The protein science of biosimilars. Nephrol Dial Transplant 21(Suppl 5):v4\u20138. doi: 10.1093\/ndt\/gfl474","journal-title":"Nephrol Dial Transplant"},{"key":"3427_CR3","unstructured":"US Food and Drug Admiistration, Troy DE (2013) Drug Price Competition and Patent Term Restoration Act of 1984 (Hatch-Waxman Amendments). US Department of Heralth & Human Services. http:\/\/www.fda.gov\/newsevents\/testimony\/ucm115033.htm . Accessed 5 July 2016"},{"key":"3427_CR4","unstructured":"US Food and Drug Administration (2011) Submission of summary bioequivalence data for ANDAs. U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER). http:\/\/www.fda.gov\/downloads\/Drugs\/GuidanceComplianceRegulatoryInformation\/Guidances\/UCM134846.pdf . Accessed 5 July 2016"},{"key":"3427_CR5","doi-asserted-by":"publisher","first-page":"221","DOI":"10.1111\/j.1742-7843.2009.00518.x","volume":"106","author":"JA Morais","year":"2010","unstructured":"Morais JA, Lobato Mdo R (2010) The new European Medicines Agency guideline on the investigation of bioequivalence. Basic Clin Pharmacol Toxicol 106:221\u2013225. doi: 10.1111\/j.1742-7843.2009.00518.x","journal-title":"Basic Clin Pharmacol Toxicol"},{"key":"3427_CR6","unstructured":"Meyer MC (2001) United States Food and Drug Administration requirements for approval of generic drug products. J Clin Psychiatry 62(Suppl 5):4\u20139, discussion 23-24"},{"key":"3427_CR7","doi-asserted-by":"publisher","first-page":"411","DOI":"10.1093\/annonc\/mdm345","volume":"19","author":"H Mellstedt","year":"2008","unstructured":"Mellstedt H, Niederwieser D, Ludwig H (2008) The challenge of biosimilars. Ann Oncol 19:411\u2013419. doi: 10.1093\/annonc\/mdm345","journal-title":"Ann Oncol"},{"issue":"Suppl 4","key":"3427_CR8","doi-asserted-by":"crossref","first-page":"S1","DOI":"10.6004\/jnccn.2011.0136","volume":"9","author":"AD Zelenetz","year":"2011","unstructured":"Zelenetz AD, Ahmed I, Braud EL, Cross JD, Davenport-Ennis N, Dickinson BD, Goldberg SE, Gottlieb S, Johnson PE, Lyman GH, Markus R, Matulonis UA, Reinke D, Li EC, DeMartino J, Larsen JK, Hoffman JM (2011) NCCN biosimilars white paper: regulatory, scientific, and patient safety perspectives. J Natl Compr Canc Netw 9(Suppl 4):S1\u201322","journal-title":"J Natl Compr Canc Netw"},{"key":"3427_CR9","doi-asserted-by":"publisher","first-page":"917","DOI":"10.1038\/nbt0910-917","volume":"28","author":"G Walsh","year":"2010","unstructured":"Walsh G (2010) Biopharmaceutical benchmarks 2010. Nat Biotechnol 28:917\u2013924. doi: 10.1038\/nbt0910-917","journal-title":"Nat Biotechnol"},{"key":"3427_CR10","unstructured":"Committee for Medicinal Products for Human Use (CHMP) (2014) Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues. European Medicines Agency. http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/Scientific_guideline\/2015\/01\/WC500180219.pdf . Accessed 5 July 2016"},{"key":"3427_CR11","unstructured":"US Food and Drug Administration (2015) Scientific considerations in demonstrating bosimilarity to a reference product. Department of Health and Human Services, Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER). http:\/\/www.fda.gov\/downloads\/Drugs\/GuidanceComplianceRegulatoryInformation\/Guidances\/UCM291128.pdf . Accessed 5 July 2016"},{"key":"3427_CR12","doi-asserted-by":"publisher","first-page":"1138","DOI":"10.1136\/annrheumdis-2013-203296","volume":"73","author":"S Garces","year":"2014","unstructured":"Garces S, Antunes M, Benito-Garcia E, da Silva JC, Aarden L, Demengeot J (2014) A preliminary algorithm introducing immunogenicity assessment in the management of patients with RA receiving tumour necrosis factor inhibitor therapies. Ann Rheum Dis 73:1138\u20131143. doi: 10.1136\/annrheumdis-2013-203296","journal-title":"Ann Rheum Dis"},{"key":"3427_CR13","doi-asserted-by":"publisher","first-page":"153","DOI":"10.1517\/14712598.2012.758710","volume":"13","author":"PJ Declerck","year":"2013","unstructured":"Declerck PJ (2013) Biosimilar monoclonal antibodies: a science-based regulatory challenge. Expert Opin Biol Ther 13:153\u2013156. doi: 10.1517\/14712598.2012.758710","journal-title":"Expert Opin Biol Ther"},{"key":"3427_CR14","doi-asserted-by":"publisher","first-page":"322","DOI":"10.1136\/annrheumdis-2012-202715","volume":"72","author":"T Dorner","year":"2013","unstructured":"Dorner T, Strand V, Castaneda-Hernandez G, Ferraccioli G, Isaacs JD, Kvien TK, Martin-Mola E, Mittendorf T, Smolen JS, Burmester GR (2013) The role of biosimilars in the treatment of rheumatic diseases. Ann Rheum Dis 72:322\u2013328. doi: 10.1136\/annrheumdis-2012-202715","journal-title":"Ann Rheum Dis"},{"key":"3427_CR15","doi-asserted-by":"publisher","first-page":"164","DOI":"10.1002\/biot.200500051","volume":"1","author":"K Graumann","year":"2006","unstructured":"Graumann K, Premstaller A (2006) Manufacturing of recombinant therapeutic proteins in microbial systems. Biotechnol J 1:164\u2013186. doi: 10.1002\/biot.200500051","journal-title":"Biotechnol J"},{"key":"3427_CR16","doi-asserted-by":"publisher","first-page":"165","DOI":"10.1007\/10_2011_101","volume":"127","author":"M Berger","year":"2012","unstructured":"Berger M, Kaup M, Blanchard V (2012) Protein glycosylation and its impact on biotechnology. Adv Biochem Eng Biotechnol 127:165\u2013185. doi: 10.1007\/10_2011_101","journal-title":"Adv Biochem Eng Biotechnol"},{"key":"3427_CR17","doi-asserted-by":"publisher","first-page":"2380","DOI":"10.1056\/NEJMp1504672","volume":"372","author":"A Sarpatwari","year":"2015","unstructured":"Sarpatwari A, Avorn J, Kesselheim AS (2015) Progress and hurdles for follow-on biologics. N Engl J Med 372:2380\u20132382. doi: 10.1056\/NEJMp1504672","journal-title":"N Engl J Med"},{"key":"3427_CR18","doi-asserted-by":"publisher","first-page":"267","DOI":"10.1159\/000105133","volume":"30","author":"M Nowicki","year":"2007","unstructured":"Nowicki M (2007) Basic facts about biosimilars. Kidney Blood Press Res 30:267\u2013272. doi: 10.1159\/000105133","journal-title":"Kidney Blood Press Res"},{"key":"3427_CR19","doi-asserted-by":"publisher","first-page":"1053","DOI":"10.1185\/03007995.2012.686902","volume":"28","author":"JF Lee","year":"2012","unstructured":"Lee JF, Litten JB, Grampp G (2012) Comparability and biosimilarity: considerations for the healthcare provider. Curr Med Res Opin 28:1053\u20131058. doi: 10.1185\/03007995.2012.686902","journal-title":"Curr Med Res Opin"},{"key":"3427_CR20","doi-asserted-by":"publisher","first-page":"363","DOI":"10.1007\/s40259-014-0088-z","volume":"28","author":"S Ramanan","year":"2014","unstructured":"Ramanan S, Grampp G (2014) Drift, evolution, and divergence in biologics and biosimilars manufacturing. BioDrugs 28:363\u2013372. doi: 10.1007\/s40259-014-0088-z","journal-title":"BioDrugs"},{"key":"3427_CR21","doi-asserted-by":"publisher","first-page":"1589","DOI":"10.1136\/annrheumdis-2012-203198","volume":"72","author":"J Kay","year":"2013","unstructured":"Kay J, Smolen JS (2013) Biosimilars to treat inflammatory arthritis: the challenge of proving identity. Ann Rheum Dis 72:1589\u20131593. doi: 10.1136\/annrheumdis-2012-203198","journal-title":"Ann Rheum Dis"},{"key":"3427_CR22","unstructured":"International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) (2014) Policy statement. Non-comparable biotherapeutic products. IFPMA. http:\/\/www.ifpma.org\/wp-content\/uploads\/2016\/02\/Non-comparable_Biotherapeutic_Products__English__02.pdf . Accessed 5 July 2016"},{"key":"3427_CR23","unstructured":"World Health Organization (2010) Guidelines on evaluation of similar biotherapeutic products (SBPs). World Health Organization. http:\/\/www.who.int\/biologicals\/areas\/biological_therapeutics\/BIOTHERAPEUTICS_FOR_WEB_22APRIL2010.pdf . Accessed 5 July 2016"},{"key":"3427_CR24","unstructured":"International Conference on Harmonisation (ICH), ICH Expert Working Group (2009) ICH harmonised tripartite gudieline: pharmaceutical development Q8 (R2): current Step 4 version. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. http:\/\/www.ich.org\/fileadmin\/Public_Web_Site\/ICH_Products\/Guidelines\/Quality\/Q8_R1\/Step4\/Q8_R2_Guideline.pdf . Accessed 5 July 2016"},{"key":"3427_CR25","unstructured":"International Conference on Harmonisation (ICH), ICH Expert Working Group (2004) ICH harmonised tripartite guideline: comparability of biotechnological\/biological products subject to changes in their manufacturing process. Q5E. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. http:\/\/www.ich.org\/fileadmin\/Public_Web_Site\/ICH_Products\/Guidelines\/Quality\/Q5E\/Step4\/Q5E_Guideline.pdf . Accessed 5 July 2016"},{"key":"3427_CR26","doi-asserted-by":"publisher","DOI":"10.1007\/s11095-015-1790-3","author":"P Declerck","year":"2015","unstructured":"Declerck P, Farouk-Rezk M, Rudd PM (2015) Biosimilarity versus manufacturing change: two distinct concepts. Pharm Res. doi: 10.1007\/s11095-015-1790-3","journal-title":"Pharm Res"},{"key":"3427_CR27","unstructured":"US Food and Drug Adminstration, Yao L (2008) Meeting of the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) to evaluate myozyme (alglucosidase alfa) for the treatment of late onset Pompe disease. Clinical background materials. US Food and Drug Administrtion, Center for Drug Evaluation and Research (CDER). http:\/\/www.fda.gov\/ohrms\/dockets\/ac\/08\/briefing\/2008-4389b1-01-FDA.pdf . Accessed 5 July 2016"},{"key":"3427_CR28","doi-asserted-by":"crossref","first-page":"209","DOI":"10.4161\/mabs.3.2.15005","volume":"3","author":"M McCamish","year":"2011","unstructured":"McCamish M, Woollett G (2011) Worldwide experience with biosimilar development. MAbs 3:209\u2013217","journal-title":"MAbs"},{"key":"3427_CR29","unstructured":"Committee for Medicinal Products for Human Use (CHMP) (2016) European public assessment reports: biosimilars. European Medicines Agency. http:\/\/www.ema.europa.eu\/ema\/index.jsp?curl=pages%2Fmedicines%2Flanding%2Fepar_search.jsp&mid=WC0b01ac058001d125&searchTab=searchByAuthType&alreadyLoaded=true&isNewQuery=true&status=Authorised&status=Withdrawn&status=Suspended&status=Refused&keyword=Enter+keywords&searchType=name&taxonomyPath=&treeNumber=&searchGenericType=biosimilars&genericsKeywordSearch=Submit . Accessed 5 July 2016"},{"key":"3427_CR30","doi-asserted-by":"publisher","first-page":"949","DOI":"10.1111\/bcp.12656","volume":"80","author":"F Mora de","year":"2015","unstructured":"de Mora F (2015) Biosimilar: what it is not. Br J Clin Pharmacol 80:949\u2013956. doi: 10.1111\/bcp.12656","journal-title":"Br J Clin Pharmacol"},{"key":"3427_CR31","doi-asserted-by":"publisher","first-page":"460","DOI":"10.1158\/2159-8290.CD-ND2015-002","volume":"5","author":"J Colwell","year":"2015","unstructured":"Colwell J (2015) FDA approves first biosimilar, Zarxio. Cancer Discov 5:460. doi: 10.1158\/2159-8290.CD-ND2015-002","journal-title":"Cancer Discov"},{"key":"3427_CR32","unstructured":"US Food and Drug Admiistration (2016) FDA approves Inflectra, a biosimilar to Remicade [news release]. US Department of Health & Human Services. http:\/\/www.fda.gov\/NewsEvents\/Newsroom\/PressAnnouncements\/ucm494227.htm . Accessed 5 July 2016"},{"key":"3427_CR33","doi-asserted-by":"publisher","first-page":"32","DOI":"10.1186\/s40697-014-0032-7","volume":"1","author":"DJ Martinusen","year":"2014","unstructured":"Martinusen DJ, Lo C, Marin JG, Tsao NW, Leung M (2014) Potential impact of subsequent entry biologics in nephrology practice in Canada. Can J Kidney Health Dis 1:32. doi: 10.1186\/s40697-014-0032-7","journal-title":"Can J Kidney Health Dis"},{"key":"3427_CR34","doi-asserted-by":"crossref","first-page":"e000010","DOI":"10.1136\/rmdopen-2014-000010","volume":"1","author":"G Casta\u00f1eda-Hern\u00e1ndez","year":"2015","unstructured":"Casta\u00f1eda-Hern\u00e1ndez G, Gonz\u00e1lez-Ram\u00edrez R, Kay J, Scheinberg MA (2015) Biosimilars in rheumatology: what the clinician should know. RMD Open 1:e000010","journal-title":"RMD Open"},{"key":"3427_CR35","doi-asserted-by":"crossref","first-page":"107","DOI":"10.4161\/mabs.3.2.14785","volume":"3","author":"A Beck","year":"2011","unstructured":"Beck A (2011) Biosimilar, biobetter and next generation therapeutic antibodies. MAbs 3:107\u2013110","journal-title":"MAbs"},{"key":"3427_CR36","doi-asserted-by":"publisher","first-page":"5111","DOI":"10.1182\/blood-2012-04-425744","volume":"120","author":"M Weise","year":"2012","unstructured":"Weise M, Bielsky MC, De Smet K, Ehmann F, Ekman N, Giezen TJ, Gravanis I, Heim HK, Heinonen E, Ho K, Moreau A, Narayanan G, Kruse NA, Reichmann G, Thorpe R, van Aerts L, Vleminckx C, Wadhwa M, Schneider CK (2012) Biosimilars: what clinicians should know. Blood 120:5111\u20135117. doi: 10.1182\/blood-2012-04-425744","journal-title":"Blood"},{"key":"3427_CR37","doi-asserted-by":"publisher","first-page":"261","DOI":"10.1007\/s11095-015-1790-3","volume":"33","author":"PJ Declerck","year":"2016","unstructured":"Declerck PJ, Farouk-Rezk M, Rudd PM (2016) Biosimilarity versus manufacturing change: two distinct concepts. Pharm Res 33:261\u2013268. doi: 10.1007\/s11095-015-1790-3","journal-title":"Pharm Res"}],"container-title":["Clinical Rheumatology"],"original-title":[],"language":"en","link":[{"URL":"http:\/\/link.springer.com\/content\/pdf\/10.1007\/s10067-016-3427-2.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"http:\/\/link.springer.com\/article\/10.1007\/s10067-016-3427-2\/fulltext.html","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"http:\/\/link.springer.com\/content\/pdf\/10.1007\/s10067-016-3427-2.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2017,6,24]],"date-time":"2017-06-24T20:58:51Z","timestamp":1498337931000},"score":1,"resource":{"primary":{"URL":"http:\/\/link.springer.com\/10.1007\/s10067-016-3427-2"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2016,10,12]]},"references-count":37,"journal-issue":{"issue":"12","published-print":{"date-parts":[[2016,12]]}},"alternative-id":["3427"],"URL":"https:\/\/doi.org\/10.1007\/s10067-016-3427-2","relation":{},"ISSN":["0770-3198","1434-9949"],"issn-type":[{"value":"0770-3198","type":"print"},{"value":"1434-9949","type":"electronic"}],"subject":[],"published":{"date-parts":[[2016,10,12]]}}}