{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,29]],"date-time":"2026-08-29T00:11:40Z","timestamp":1787962300762,"version":"build-2784847793"},"reference-count":20,"publisher":"Springer Science and Business Media LLC","issue":"1","license":[{"start":{"date-parts":[[2018,8,15]],"date-time":"2018-08-15T00:00:00Z","timestamp":1534291200000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"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":["Arthritis Res Ther"],"published-print":{"date-parts":[[2018,12]]},"DOI":"10.1186\/s13075-018-1676-y","type":"journal-article","created":{"date-parts":[[2018,8,15]],"date-time":"2018-08-15T08:24:27Z","timestamp":1534321467000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":50,"title":["A comparative clinical study of PF-06410293, a candidate adalimumab biosimilar, and adalimumab reference product (Humira\u00ae) in the treatment of active rheumatoid arthritis"],"prefix":"10.1186","volume":"20","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-6630-1477","authenticated-orcid":false,"given":"Roy M.","family":"Fleischmann","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rieke","family":"Alten","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Margarita","family":"Pileckyte","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kasia","family":"Lobello","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Steven Y.","family":"Hua","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Carol","family":"Cronenberger","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Daniel","family":"Alvarez","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Amy E.","family":"Bock","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"K. Lea","family":"Sewell","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2018,8,15]]},"reference":[{"key":"1676_CR1","doi-asserted-by":"publisher","first-page":"679","DOI":"10.1016\/j.clinthera.2011.05.044","volume":"33","author":"JR Curtis","year":"2011","unstructured":"Curtis JR, Singh JA. Use of biologics in rheumatoid arthritis: current and emerging paradigms of care. Clin Ther. 2011;33:679\u2013707. \n                    https:\/\/doi.org\/10.1016\/j.clinthera.2011.05.044\n                    \n                  .","journal-title":"Clin Ther."},{"key":"1676_CR2","doi-asserted-by":"publisher","first-page":"35","DOI":"10.1002\/art.10697","volume":"48","author":"ME Weinblatt","year":"2003","unstructured":"Weinblatt ME, Keystone EC, Furst DE, Moreland LW, Weisman MH, Birbara CA, et al. Adalimumab, a fully human anti-tumor necrosis factor alpha monoclonal antibody, for the treatment of rheumatoid arthritis in patients taking concomitant methotrexate: the ARMADA trial. Arthritis Rheum. 2003;48:35\u201345. \n                    https:\/\/doi.org\/10.1002\/art.10697\n                    \n                  .","journal-title":"Arthritis Rheum."},{"key":"1676_CR3","doi-asserted-by":"publisher","first-page":"1400","DOI":"10.1002\/art.20217","volume":"50","author":"EC Keystone","year":"2004","unstructured":"Keystone EC, Kavanaugh AF, Sharp JT, Tannenbaum H, Hua Y, Teoh LS, et al. Radiographic, clinical, and functional outcomes of treatment with adalimumab (a human anti-tumor necrosis factor monoclonal antibody) in patients with active rheumatoid arthritis receiving concomitant methotrexate therapy: a randomized, placebo-controlled, 52-week trial. Arthritis Rheum. 2004;50:1400\u201311. \n                    https:\/\/doi.org\/10.1002\/art.20217\n                    \n                  .","journal-title":"Arthritis Rheum."},{"key":"1676_CR4","doi-asserted-by":"publisher","first-page":"26","DOI":"10.1002\/art.21519","volume":"54","author":"FC Breedveld","year":"2006","unstructured":"Breedveld FC, Weisman MH, Kavanaugh AF, Cohen SB, Pavelka K, van Vollenhoven R, et al. The PREMIER study: a multicenter, randomized, double-blind clinical trial of combination therapy with adalimumab plus methotrexate versus methotrexate alone or adalimumab alone in patients with early, aggressive rheumatoid arthritis who had not had previous methotrexate treatment. Arthritis Rheum. 2006;54:26\u201337. \n                    https:\/\/doi.org\/10.1002\/art.21519\n                    \n                  .","journal-title":"Arthritis Rheum."},{"key":"1676_CR5","volume-title":"HUMIRA (adalimumab) summary of product characteristics","author":"European Medicines Agency","year":"2017","unstructured":"European Medicines Agency. HUMIRA (adalimumab) summary of product characteristics. 2017 (last update: 10 May 2017). \n                    http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/EPAR_-_Product_Information\/human\/000481\/WC500050870.pdf\n                    \n                  . Accessed 19 Feb. 2018."},{"key":"1676_CR6","volume-title":"HUMIRA (adalimumab) package insert","author":"Abbott Laboratories","year":"2003","unstructured":"Abbott Laboratories. HUMIRA (adalimumab) package insert. 2003 (last update: 26 September 2003). \n                    https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2002\/adalabb123102LB.htm\n                    \n                  . Accessed 19 Feb. 2018."},{"key":"1676_CR7","volume-title":"Scientific considerations in demonstrating biosimilarity to a reference product. Guidance for industry","author":"US Food and Drug Administration","year":"2015","unstructured":"US Food and Drug Administration. Scientific considerations in demonstrating biosimilarity to a reference product. Guidance for industry. 2015 (last update: April 2015). \n                    https:\/\/www.fda.gov\/downloads\/drugs\/guidances\/ucm291128.pdf\n                    \n                  . Accessed 19 Feb. 2018."},{"key":"1676_CR8","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 (last update: July 2014). \n                    http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/Scientific_guideline\/2014\/10\/WC500176768.pdf\n                    \n                  . Accessed 19 Feb. 2018."},{"key":"1676_CR9","volume-title":"The impact of biosimilar competition in Europe","author":"QuintilesIMS","year":"2017","unstructured":"QuintilesIMS. The impact of biosimilar competition in Europe. 2017 (last update: May 2017). \n                    http:\/\/www.medicinesforeurope.com\/wp-content\/uploads\/2017\/05\/IMS-Biosimilar-2017_V9.pdf\n                    \n                  . Accessed 19 Feb. 2018."},{"key":"1676_CR10","volume-title":"The cost savings potential of biosimilar drugs in the United States","author":"A Mulcahy","year":"2014","unstructured":"Mulcahy A, Predmore Z, Soeren M. The cost savings potential of biosimilar drugs in the United States. 2014. \n                    https:\/\/www.rand.org\/content\/dam\/rand\/pubs\/perspectives\/PE100\/PE127\/RAND_PE127.pdf\n                    \n                  . Accessed 19 Feb. 2018."},{"key":"1676_CR11","doi-asserted-by":"publisher","first-page":"e15","DOI":"10.1016\/j.japh.2017.05.014","volume":"57","author":"J Crespi-Lofton","year":"2017","unstructured":"Crespi-Lofton J, Skelton JB. The growing role of biologics and biosimilars in the United States: Perspectives from the APhA Biologics and Biosimilars Stakeholder Conference. J Am Pharm Assoc (2003). 2017;57:e15\u201327. \n                    https:\/\/doi.org\/10.1016\/j.japh.2017.05.014\n                    \n                  .","journal-title":"J Am Pharm Assoc (2003)"},{"key":"1676_CR12","volume-title":"Society of Toxicology 53rd Annual Meeting and ToxExpo 2014; Phoenix, Arizona","author":"D Derzi","year":"2014","unstructured":"Derzi D, Ripp S, Ng C, Shoieb A, Finch G, Lorello L, et al. Comparative nonclinical assessments of the potential biosimilar PF-06410293 and adalimumab [abstract no. 276]. In: Society of Toxicology 53rd Annual Meeting and ToxExpo 2014; Phoenix, Arizona; 2014."},{"key":"1676_CR13","unstructured":"ClinicalTrials.gov. A study of PF-06410293 (adalimumab-Pfizer) and adalimumab (Humira) In healthy subjects (REFLECTIONS B538\u201307)) (B538\u201307). 2014 (last update: 13 April 2015). \n                    https:\/\/clinicaltrials.gov\/ct2\/show\/NCT02237729\n                    \n                  . Accessed 19 Feb. 2018."},{"key":"1676_CR14","doi-asserted-by":"publisher","first-page":"2569","DOI":"10.1002\/art.27584","volume":"62","author":"D Aletaha","year":"2010","unstructured":"Aletaha D, Neogi T, Silman AJ, Funovits J, Felson DT, Bingham CO 3rd, et al. 2010 rheumatoid arthritis classification criteria: an American College of Rheumatology\/European league against rheumatism collaborative initiative. Arthritis Rheum. 2010;62:2569\u201381. \n                    https:\/\/doi.org\/10.1002\/art.27584\n                    \n                  .","journal-title":"Arthritis Rheum."},{"key":"1676_CR15","doi-asserted-by":"publisher","first-page":"727","DOI":"10.1002\/art.1780380602","volume":"38","author":"DT Felson","year":"1995","unstructured":"Felson DT, Anderson JJ, Boers M, Bombardier C, Furst D, Goldsmith C, et al. American College of Rheumatology. Preliminary definition of improvement in rheumatoid arthritis. Arthritis Rheum. 1995;38:727\u201335.","journal-title":"Arthritis Rheum."},{"key":"1676_CR16","doi-asserted-by":"publisher","first-page":"1132","DOI":"10.1136\/annrheumdis-2013-204920","volume":"74","author":"R Fleischmann","year":"2015","unstructured":"Fleischmann R, van der Heijde D, Koenig AS, Pedersen R, Szumski A, Marshall L, et al. How much does disease activity score in 28 joints ESR and CRP calculations underestimate disease activity compared with the simplified disease activity index? Ann Rheum Dis. 2015;74:1132\u20137. \n                    https:\/\/doi.org\/10.1136\/annrheumdis-2013-204920\n                    \n                  .","journal-title":"Ann Rheum Dis."},{"key":"1676_CR17","doi-asserted-by":"publisher","first-page":"9","DOI":"10.1111\/j.1479-8077.2007.00248.x","volume":"10","author":"HY Kim","year":"2007","unstructured":"Kim HY, Lee SK, Song YW, Yoo DH, Koh EM, Yoo B, et al. A randomized, double-blind, placebo-controlled, phase III study of the human anti-tumor necrosis factor antibody adalimumab administered as subcutaneous injections in Korean rheumatoid arthritis patients treated with methotrexate. APLAR J Rheumatol. 2007;10:9\u201316. \n                    https:\/\/doi.org\/10.1111\/j.1479-8077.2007.00248.x\n                    \n                  .","journal-title":"APLAR J Rheumatol."},{"key":"1676_CR18","doi-asserted-by":"publisher","first-page":"310","DOI":"10.1016\/S0929-6646(09)60071-1","volume":"108","author":"DY Chen","year":"2009","unstructured":"Chen DY, Chou SJ, Hsieh TY, Chen YH, Chen HH, Hsieh CW, et al. Randomized, double-blind, placebo-controlled, comparative study of human anti-TNF antibody adalimumab in combination with methotrexate and methotrexate alone in Taiwanese patients with active rheumatoid arthritis. J Formos Med Assoc. 2009;108:310\u20139. \n                    https:\/\/doi.org\/10.1016\/S0929-6646(09)60071-1\n                    \n                  .","journal-title":"J Formos Med Assoc"},{"key":"1676_CR19","doi-asserted-by":"publisher","first-page":"213","DOI":"10.1002\/sim.4780040211","volume":"4","author":"O Miettinen","year":"1985","unstructured":"Miettinen O, Nurminen M. Comparative analysis of two rates. Stat Med. 1985;4:213\u201326.","journal-title":"Stat Med."},{"key":"1676_CR20","doi-asserted-by":"publisher","first-page":"658","DOI":"10.1208\/s12248-014-9599-2","volume":"16","author":"G Shankar","year":"2014","unstructured":"Shankar G, Arkin S, Cocea L, Devanarayan V, Kirshner S, Kromminga A, et al. Assessment and reporting of the clinical immunogenicity of therapeutic proteins and peptides-harmonized terminology and tactical recommendations. AAPS J. 2014;16:658\u201373. \n                    https:\/\/doi.org\/10.1208\/s12248-014-9599-2\n                    \n                  .","journal-title":"AAPS J."}],"container-title":["Arthritis Research &amp; Therapy"],"original-title":[],"language":"en","link":[{"URL":"http:\/\/link.springer.com\/content\/pdf\/10.1186\/s13075-018-1676-y.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"http:\/\/link.springer.com\/article\/10.1186\/s13075-018-1676-y\/fulltext.html","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"http:\/\/link.springer.com\/content\/pdf\/10.1186\/s13075-018-1676-y.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2019,9,21]],"date-time":"2019-09-21T11:42:14Z","timestamp":1569066134000},"score":1,"resource":{"primary":{"URL":"https:\/\/arthritis-research.biomedcentral.com\/articles\/10.1186\/s13075-018-1676-y"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2018,8,15]]},"references-count":20,"journal-issue":{"issue":"1","published-print":{"date-parts":[[2018,12]]}},"alternative-id":["1676"],"URL":"https:\/\/doi.org\/10.1186\/s13075-018-1676-y","relation":{},"ISSN":["1478-6362"],"issn-type":[{"value":"1478-6362","type":"electronic"}],"subject":[],"published":{"date-parts":[[2018,8,15]]},"assertion":[{"value":"21 March 2018","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"13 July 2018","order":2,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"15 August 2018","order":3,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"This study was conducted in compliance with the ethical principles of the Declaration of Helsinki and in compliance with all International Conference on Harmonization Good Clinical Practice Guidelines. The study protocol, all amendments, and informed consent documentation were reviewed and approved by the institutional review boards or independent ethics committees or both. In addition, all local regulatory requirements were followed. All patients provided informed consent before undergoing any screening procedures.","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":"RMF has received research grants and consulting fees from Pfizer Inc. and AbbVie. RA has received research grants and honoraria from Pfizer Inc. MP declares that she has no competing interests. SYH was an employee of and held stock holdings or stock options (or both) from Pfizer Inc. at the time of the study. KL, CC, DA, AEB, and KLS are full-time employees of and declare stock holdings or stock options (or both) from Pfizer Inc.","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":"178"}}