{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,29]],"date-time":"2026-08-29T00:11:59Z","timestamp":1787962319919,"version":"build-2784847793"},"reference-count":31,"publisher":"Springer Science and Business Media LLC","issue":"1","license":[{"start":{"date-parts":[[2019,3,29]],"date-time":"2019-03-29T00:00:00Z","timestamp":1553817600000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/100002429","name":"Amgen","doi-asserted-by":"publisher","award":["n\/a"],"award-info":[{"award-number":["n\/a"]}],"id":[{"id":"10.13039\/100002429","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Arthritis Res Ther"],"published-print":{"date-parts":[[2019,12]]},"DOI":"10.1186\/s13075-019-1857-3","type":"journal-article","created":{"date-parts":[[2019,3,29]],"date-time":"2019-03-29T03:05:25Z","timestamp":1553828725000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":34,"title":["An open-label extension study to demonstrate long-term safety and efficacy of ABP 501 in patients with rheumatoid arthritis"],"prefix":"10.1186","volume":"21","author":[{"given":"Stanley","family":"Cohen","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jose L.","family":"Pablos","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Karel","family":"Pavelka","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gerard Anton","family":"M\u00fcller","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alan","family":"Matsumoto","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alan","family":"Kivitz","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hui","family":"Wang","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Eswar","family":"Krishnan","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2019,3,29]]},"reference":[{"issue":"3","key":"1857_CR1","doi-asserted-by":"publisher","first-page":"190","DOI":"10.1016\/0049-0172(90)90060-S","volume":"20","author":"R Segal","year":"1990","unstructured":"Segal R, Yaron M, Tartakovsky B. Methotrexate: mechanism of action in rheumatoid arthritis. Semin Arthritis Rheum. 1990;20(3):190\u2013200.","journal-title":"Semin Arthritis Rheum"},{"key":"1857_CR2","doi-asserted-by":"publisher","unstructured":"D\u00f6rner T, Strand V, Cornes P, Gon\u00e7alves J, Gul\u00e1csi L, Kay J, et al. The changing landscape of biosimilars in rheumatology. Ann Rheum Dis. 2016. \n                    https:\/\/doi.org\/10.1136\/annrheumdis-2016-209166\n                    \n                  .","DOI":"10.1136\/annrheumdis-2016-209166"},{"issue":"4","key":"1857_CR3","first-page":"3","volume":"7","author":"AW Mulcahy","year":"2018","unstructured":"Mulcahy AW, Hlavka JP, Case SR. Biosimilar cost savings in the United States: initial experience and future potential. Rand Health Q. 2018;7(4):3.","journal-title":"Rand Health Q"},{"issue":"6","key":"1857_CR4","first-page":"329","volume":"38","author":"CL Ventola","year":"2013","unstructured":"Ventola CL. Biosimilars: part 2: potential concerns and challenges for p&t committees. P T. 2013;38(6):329\u201335.","journal-title":"P T"},{"key":"1857_CR5","doi-asserted-by":"publisher","unstructured":"Ara\u00fajo FC, Gon\u00e7alves J, Fonseca JE. Pharmacoeconomics of biosimilars: what is there to gain from them? Curr Rheumatol Rep. 2016. \n                    https:\/\/doi.org\/10.1007\/s11926-016-0601-0\n                    \n                  .","DOI":"10.1007\/s11926-016-0601-0"},{"key":"1857_CR6","doi-asserted-by":"publisher","unstructured":"Gul\u00e1csi L, Brodszky V, Baji P, Kim H, Kim SY, Cho YY, P\u00e9ntek M. Biosimilars for the management of rheumatoid arthritis: economic considerations. Expert Rev Clin Immunol. 2015. \n                    https:\/\/doi.org\/10.1586\/1744666X.2015.1090313\n                    \n                  .","DOI":"10.1586\/1744666X.2015.1090313"},{"key":"1857_CR7","volume-title":"Guideline on similar biological medicinal products","author":"European Medicines Agency","year":"2013","unstructured":"European Medicines Agency. Guideline on similar biological medicinal products. 2013. \n                    http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/Scientific_guideline\/2013\/05\/WC500142978.pdf\n                    \n                  . Accessed 17 Aug 2018."},{"key":"1857_CR8","unstructured":"European Medicines Agency. Questions and answers on biosimilar medicines (similar biological medicinal products). Available at: \n                    https:\/\/www.medicinesforeurope.com\/wp-content\/uploads\/2016\/03\/WC500020062.pdf\n                    \n                  . Accessed Aug 31."},{"key":"1857_CR9","volume-title":"Biosimilars: questions and answers regarding implementation of the biologics price competition and innovation act of 2009","author":"US Food and Drug Administration","year":"2015","unstructured":"US Food and Drug Administration. Biosimilars: questions and answers regarding implementation of the biologics price competition and innovation act of 2009. 2015. \n                    https:\/\/www.fda.gov\/downloads\/Drugs\/GuidanceComplianceRegulatoryInformation\/Guidances\/UCM444661.pdf\n                    \n                  . Accessed 17 Aug 2018."},{"key":"1857_CR10","volume-title":"Quality considerations in demonstrating biosimilarity of a therapeutic protein product to a reference product","author":"US Food and Drug Administration","year":"2015","unstructured":"US Food and Drug Administration. Quality considerations in demonstrating biosimilarity of a therapeutic protein product to a reference product. 2015. \n                    https:\/\/www.fda.gov\/downloads\/Drugs\/GuidanceComplianceRegulatoryInformation\/Guidances\/UCM291134.pdf\n                    \n                  . Accessed 17 Aug 2018."},{"key":"1857_CR11","volume-title":"Scientific considerations in demonstrating biosimilarity to a reference product","author":"US Food and Drug Administration","year":"2015","unstructured":"US Food and Drug Administration. Scientific considerations in demonstrating biosimilarity to a reference product. 2015. \n                    https:\/\/www.fda.gov\/downloads\/Drugs\/GuidanceComplianceRegulatoryInformation\/Guidances\/UCM291128.pdf\n                    \n                  . Accessed 17 Aug 2018."},{"key":"1857_CR12","volume-title":"Clinical pharmacology data to support a demonstration of biosimilarity to a reference product","author":"US Food and Drug Administration","year":"2016","unstructured":"US Food and Drug Administration. Clinical pharmacology data to support a demonstration of biosimilarity to a reference product. 2016. \n                    https:\/\/www.fda.gov\/downloads\/Drugs\/GuidanceComplianceRegulatoryInformation\/Guidances\/UCM397017.pdf\n                    \n                  . Accessed 17 Aug 2018."},{"key":"1857_CR13","volume-title":"Guideline for the quality, safety, and efficacy assurance of follow-on biologics","author":"The Pharmaceuticals and Medical Devices Agency","year":"2009","unstructured":"The Pharmaceuticals and Medical Devices Agency. Guideline for the quality, safety, and efficacy assurance of follow-on biologics. 2009. \n                    https:\/\/www.pmda.go.jp\/files\/000153851.pdf\n                    \n                  . Accessed 17 Aug 2018."},{"key":"1857_CR14","volume-title":"Guideline on similar biological medicinal products","author":"European Medicines Agency","year":"2014","unstructured":"European Medicines Agency. Guideline on similar biological medicinal products. 2014. \n                    http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/Scientific_guideline\/2014\/10\/WC500176768.pdf\n                    \n                  . Accessed 17 Aug 2018."},{"key":"1857_CR15","doi-asserted-by":"publisher","unstructured":"Markus R, Liu J, Ramchandani M, Landa D, Born T, Kaur P. Developing the totality of evidence for biosimilars: regulatory considerations and building confidence for the healthcare community. BioDrugs. 2017. \n                    https:\/\/doi.org\/10.1007\/s40259-017-0218-5\n                    \n                  .","DOI":"10.1007\/s40259-017-0218-5"},{"key":"1857_CR16","doi-asserted-by":"publisher","unstructured":"Alten R, Cronstein BN. Clinical trial development for biosimilars. Semin Arthritis Rheum. 2015. \n                    https:\/\/doi.org\/10.1016\/j.semarthrit.2015.04.002\n                    \n                  .","DOI":"10.1016\/j.semarthrit.2015.04.002"},{"key":"1857_CR17","doi-asserted-by":"publisher","unstructured":"Olech E. Biosimilars: rationale and current regulatory landscape. Semin Arthritis Rheum. 2016. \n                    https:\/\/doi.org\/10.1016\/j.semarthrit.2016.01.001\n                    \n                  .","DOI":"10.1016\/j.semarthrit.2016.01.001"},{"key":"1857_CR18","doi-asserted-by":"publisher","unstructured":"Al-Sabbagh A, Olech E, McClellan JE, Kirchhoff CF. Development of biosimilars. Semin Arthritis Rheum. 2016. \n                    https:\/\/doi.org\/10.1016\/j.semarthrit.2016.01.002\n                    \n                  .","DOI":"10.1016\/j.semarthrit.2016.01.002"},{"key":"1857_CR19","unstructured":"European Medicines Agency. European public assessment reports. 2018. \n                    https:\/\/www.ema.europa.eu\/en\/medicines\/download-medicine-data\n                    \n                  . Accessed 17 Aug 2018."},{"key":"1857_CR20","volume-title":"FDA-approved biosimilar products","author":"US Food and Drug Administration","year":"2018","unstructured":"US Food and Drug Administration. FDA-approved biosimilar products. 2018. \n                    https:\/\/www.fda.gov\/drugs\/developmentapprovalprocess\/howdrugsaredevelopedandapproved\/approvalapplications\/therapeuticbiologicapplications\/biosimilars\/ucm580432.htm\n                    \n                  . Accessed 17 Aug 2018."},{"issue":"4","key":"1857_CR21","doi-asserted-by":"publisher","first-page":"321","DOI":"10.1007\/s40259-016-0184-3","volume":"30","author":"J Liu","year":"2016","unstructured":"Liu J, Eris T, Li C, Cao S, Kuhns S. Assessing analytical similarity of proposed Amgen biosimilar ABP 501 to adalimumab. BioDrugs. 2016;30(4):321\u201338.","journal-title":"BioDrugs."},{"issue":"4","key":"1857_CR22","doi-asserted-by":"publisher","first-page":"339","DOI":"10.1007\/s40259-016-0185-2","volume":"30","author":"J Velayudhan","year":"2016","unstructured":"Velayudhan J, Chen YF, Rohrbach A, Pastula C, Maher G, Thomas H, et al. Demonstration of functional similarity of proposed biosimilar ABP 501 to adalimumab. BioDrugs. 2016;30(4):339\u201351.","journal-title":"BioDrugs."},{"key":"1857_CR23","doi-asserted-by":"publisher","unstructured":"Papp K, Bachelez H, Costanzo A, Foley P, Gooderham M, Kaur P, et al. Clinical similarity of biosimilar ABP 501 to adalimumab in the treatment of patients with moderate to severe plaque psoriasis: a randomized, double-blind, multicenter, phase III study. J Am Acad Dermatol. 2017. \n                    https:\/\/doi.org\/10.1016\/j.jaad.2016.12.014\n                    \n                  .","DOI":"10.1016\/j.jaad.2016.12.014"},{"key":"1857_CR24","doi-asserted-by":"publisher","unstructured":"Papp K, Bachelez H, Costanzo A, Foley P, Gooderham M, Kaur P, et al. Clinical similarity of the biosimilar ABP 501 compared with adalimumab after single transition: long-term results from a randomized controlled, double-blind, 52-week, phase III trial in patients with moderate-to-severe plaque psoriasis. Br J Dermatol. 2017. \n                    https:\/\/doi.org\/10.1111\/bjd.15857\n                    \n                  .","DOI":"10.1111\/bjd.15857"},{"key":"1857_CR25","doi-asserted-by":"publisher","unstructured":"Cohen S, Genovese MC, Choy E, Perez-Ruiz F, Matsumoto A, Pavelka K, et al. Efficacy and safety of the biosimilar ABP 501 compared with adalimumab in patients with moderate to severe rheumatoid arthritis: a randomised, double-blind, phase III equivalence study. Ann Rheum Dis. 2017. \n                    https:\/\/doi.org\/10.1136\/annrheumdis-2016-210459\n                    \n                  .","DOI":"10.1136\/annrheumdis-2016-210459"},{"issue":"9","key":"1857_CR26","doi-asserted-by":"publisher","first-page":"1552","DOI":"10.1002\/1529-0131(199809)41:9<1552::AID-ART5>3.0.CO;2-W","volume":"41","author":"RN Maini","year":"1998","unstructured":"Maini RN, Breedveld FC, Kalden JR, Smolen JS, Davis D, Macfarlane JD, et al. Therapeutic efficacy of multiple intravenous infusions of anti-tumor necrosis factor alpha monoclonal antibody combined with low-dose weekly methotrexate in rheumatoid arthritis. Arthritis Rheum. 1998;41(9):1552\u201363.","journal-title":"Arthritis Rheum"},{"key":"1857_CR27","doi-asserted-by":"publisher","unstructured":"Pascual-Salcedo D, Plasencia C, Ramiro S, Nu\u00f1o L, Bonilla G, Nagore D, et al. Influence of immunogenicity on the efficacy of long-term treatment with infliximab in rheumatoid arthritis. Rheumatology (Oxford). 2011. \n                    https:\/\/doi.org\/10.1093\/rheumatology\/ker124\n                    \n                  .","DOI":"10.1093\/rheumatology\/ker124"},{"issue":"12","key":"1857_CR28","doi-asserted-by":"publisher","first-page":"3782","DOI":"10.1002\/art.22214","volume":"54","author":"K Bendtzen","year":"2006","unstructured":"Bendtzen K, Geborek P, Svenson M, Larsson L, Kapetanovic MC, Saxne T. Individualized monitoring of drug bioavailability and immunogenicity in rheumatoid arthritis patients treated with the tumor necrosis factor alpha inhibitor infliximab. Arthritis Rheum. 2006;54(12):3782\u20139.","journal-title":"Arthritis Rheum"},{"key":"1857_CR29","doi-asserted-by":"publisher","unstructured":"Jani M, Barton A, Warren RB, Griffiths CE, Chinoy H. The role of DMARDs in reducing the immunogenicity of TNF inhibitors in chronic inflammatory diseases. Rheumatology (Oxford). 2014. \n                    https:\/\/doi.org\/10.1093\/rheumatology\/ket260\n                    \n                  .","DOI":"10.1093\/rheumatology\/ket260"},{"key":"1857_CR30","doi-asserted-by":"publisher","unstructured":"Krieckaert CL, Bartelds GM, Lems WF, Wolbink GJ. The effect of immunomodulators on the immunogenicity of TNF-blocking therapeutic monoclonal antibodies: a review. Arthritis Res Ther. 2010. \n                    https:\/\/doi.org\/10.1186\/ar3147\n                    \n                  .","DOI":"10.1186\/ar3147"},{"key":"1857_CR31","unstructured":"European Medicines Agency. Summary of product characteristics. Humira (adalimumab). 2018. \n                    https:\/\/www.ema.europa.eu\/documents\/product-information\/humira-epar-product-information_en.pdf\n                    \n                  ."}],"container-title":["Arthritis Research &amp; Therapy"],"original-title":[],"language":"en","link":[{"URL":"http:\/\/link.springer.com\/content\/pdf\/10.1186\/s13075-019-1857-3.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"http:\/\/link.springer.com\/article\/10.1186\/s13075-019-1857-3\/fulltext.html","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"http:\/\/link.springer.com\/content\/pdf\/10.1186\/s13075-019-1857-3.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2020,3,28]],"date-time":"2020-03-28T00:17:27Z","timestamp":1585354647000},"score":1,"resource":{"primary":{"URL":"https:\/\/arthritis-research.biomedcentral.com\/articles\/10.1186\/s13075-019-1857-3"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2019,3,29]]},"references-count":31,"journal-issue":{"issue":"1","published-print":{"date-parts":[[2019,12]]}},"alternative-id":["1857"],"URL":"https:\/\/doi.org\/10.1186\/s13075-019-1857-3","relation":{},"ISSN":["1478-6362"],"issn-type":[{"value":"1478-6362","type":"electronic"}],"subject":[],"published":{"date-parts":[[2019,3,29]]},"assertion":[{"value":"31 August 2018","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"4 March 2019","order":2,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"29 March 2019","order":3,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"This study was conducted in compliance with Institutional Review Board (IRB)\/Independent Ethics Committee (IEC) and International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) Guidelines - including Title 21 Part 56 of the US Code of Federal Regulations (CFR) relating to IRBs\/IECs and GCP as described in the US Food and Drug Administration (FDA) CFR (21 CFR \u00a7 50, 56, 312) in accordance with applicable ICH regulations regarding clinical safety data management (E2A, E2B [R3]), European Community directives 2001\/20, 2001\/83, 2003\/94 and 2005\/28 as enacted into local law, and with ICH guidelines regarding scientific integrity (E4, E8, E9, and E10). In addition, this study was conducted in adherence to all local regulatory requirements, and requirements for data protection.","order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}},{"value":"Not applicable.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"Stanley Cohen is a consultant and investigator at Amgen, Abbvie, Boehringer Ingelheim, Coherus, Merck, Pfizer, and Sandoz.Jos\u00e9 Luis Pablos received honoraria for lectures and consultations from the following companies: BMS, Celgene, Gilead, Janssen, Lilly, Novartis, Pfizer, Roche, and Sanofi, and is also an investigator at Amgen.Karel Pavelka received honoraria for lectures and consultations from the following companies: AbbVie, Amgen, Biogen, BMS, MSD, Pfizer, Roche, and UCB.Gerard Anton M\u00fcller is an investigator at Amgen.Alan Matsumoto is a consultant and investigator at Amgen, Abbvie, Pfizer, and Takeda.Alan Kivitz is a consultant and part of the speakers\u2019 bureau at Amgen, Abbvie, Pfizer, UCB, Merck, and Sanofi-Regeneron.Hui Wang is an employee and stockholder at Amgen.Eswar Krishnan is an employee and stockholder at Amgen (at the time this work was done).","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}},{"value":"Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Publisher\u2019s Note"}}],"article-number":"84"}}