{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,10]],"date-time":"2026-09-10T15:01:15Z","timestamp":1789052475518,"version":"build-2803163510"},"reference-count":26,"publisher":"Springer Science and Business Media LLC","issue":"2","license":[{"start":{"date-parts":[[2020,2,12]],"date-time":"2020-02-12T00:00:00Z","timestamp":1581465600000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0"},{"start":{"date-parts":[[2020,2,12]],"date-time":"2020-02-12T00:00:00Z","timestamp":1581465600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0"}],"funder":[{"name":"This study was funded by Dr Reddy's Laboratories"}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["BioDrugs"],"published-print":{"date-parts":[[2020,4]]},"DOI":"10.1007\/s40259-020-00406-1","type":"journal-article","created":{"date-parts":[[2020,2,12]],"date-time":"2020-02-12T11:03:04Z","timestamp":1581505384000},"page":"183-196","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":20,"title":["Pharmacokinetic Similarity and Comparative Pharmacodynamics, Safety, Efficacy, and Immunogenicity of DRL_RI Versus Reference Rituximab in Biologics-Na\u00efve Patients with Moderate-to-Severe Rheumatoid Arthritis: A Double-Blind, Randomized, Three-Arm Study"],"prefix":"10.1007","volume":"34","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-2607-2013","authenticated-orcid":false,"given":"Vikram Muralidhar","family":"Haridas","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rahul","family":"Katta","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ajit","family":"Nalawade","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sandeep","family":"Kharkar","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Vyacheslav","family":"Zhdan","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Olena","family":"Garmish","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0620-6133","authenticated-orcid":false,"given":"Luis","family":"Lopez-Lazaro","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3220-6567","authenticated-orcid":false,"given":"Sonica Sachdeva","family":"Batra","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2267-2778","authenticated-orcid":false,"given":"Suresh","family":"Kankanwadi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2020,2,12]]},"reference":[{"key":"406_CR1","unstructured":"European Medicines Agency. Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues dated 18 December 2014. Document Reference EMEA\/CHMP\/BMWP\/42832\/2005 Rev1. http:\/\/www.ema.europa.eu\/docs\/en_GB\/document library\/Scientific guideline\/2015\/01\/WC500180219.pdf. Accessed 13 Aug 2019."},{"key":"406_CR2","unstructured":"US Food and Drugs Administration. Clinical pharmacology data to support a demonstration of biosimilarity to a reference product. https:\/\/www.fda.gov\/media\/88622\/download Accessed 21 Nov 2019."},{"key":"406_CR3","unstructured":"Rituxan (rituximab) 100\u00a0mg\/10\u00a0mL and 500\u00a0mg\/50\u00a0mL, injection for intravenous use\u2014United States prescribing information, 2019. https:\/\/www.gene.com\/ download\/pdf\/rituxan prescribing.pdf. Accessed 13 Aug 2019."},{"key":"406_CR4","doi-asserted-by":"publisher","first-page":"1316","DOI":"10.1136\/annrheumdis-2013-204627","volume":"73","author":"M Cross","year":"2014","unstructured":"Cross M, Smith E, Hoy D, et al. The global burden of rheumatoid arthritis: estimates from the Global Burden of Disease 2010 study. Ann Rheum Dis. 2014;73:1316\u201322.","journal-title":"Ann Rheum Dis"},{"key":"406_CR5","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.","journal-title":"Clin Ther"},{"issue":"2","key":"406_CR6","doi-asserted-by":"publisher","first-page":"99","DOI":"10.1007\/s40744-015-0016-9","volume":"2","author":"MD Cohen","year":"2015","unstructured":"Cohen MD, Keystone E. Rituximab for rheumatoid arthritis. Rheumatol Ther. 2015;2(2):99\u2013111.","journal-title":"Rheumatol Ther."},{"key":"406_CR7","doi-asserted-by":"publisher","first-page":"2191","DOI":"10.1001\/jama.2013.281053","volume":"310","author":"World Medical Association","year":"2013","unstructured":"World Medical Association. World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects. JAMA. 2013;310:2191\u20134.","journal-title":"JAMA"},{"key":"406_CR8","unstructured":"International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. ICH Harmonized Tripartite Guideline. Guideline for Good Clinical Practice E6(R1) 1996. http:\/\/www.ich.org\/fileadmin\/PublicWeb_Site\/ICH_Products\/Guidelines\/Efficacy\/E6\/E6_R1_Guideline.pdf. Accessed on 13 Augt 2019."},{"key":"406_CR9","unstructured":"American College of Rheumatology. ACR endorsed criteria. From 1987 ACR criteria. http:\/\/www.rheumatology.org\/practice\/clinical\/classification\/ra\/ra.asp. Accessed 27 Dec 2018."},{"key":"406_CR10","unstructured":"DAS Score Website. https:\/\/www.das-score.nl\/das28\/en\/ Accessed 5 Jan 2020."},{"key":"406_CR11","unstructured":"MabThera 100\u00a0mg concentrate for solution for infusion\u2014Summary of Product Characteristics (SPC). https:\/\/www.ema.europa.eu\/en\/documents\/product-information\/mabthera-epar-product-information_en.pdf. Accessed on 13 Aug 2019."},{"issue":"6","key":"406_CR12","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, et al. American College of Rheumatology. Preliminary definition of improvement in rheumatoid arthritis. Arthritis Rheum. 1995;38(6):727\u201335.","journal-title":"Arthritis Rheum."},{"issue":"2","key":"406_CR13","doi-asserted-by":"publisher","first-page":"137","DOI":"10.1002\/art.1780230202","volume":"23","author":"JF Fries","year":"1980","unstructured":"Fries JF, Spitz P, Kraines RG, Holman HR. Measurement of patient outcome in arthritis. Arthritis Rheum. 1980;23(2):137\u201345.","journal-title":"Arthritis Rheum"},{"issue":"1\u20132","key":"406_CR14","doi-asserted-by":"publisher","first-page":"65","DOI":"10.1002\/sim.4780090113","volume":"9","author":"J Wittes","year":"1990","unstructured":"Wittes J, Brittain E. The role of internal pilot studies in increasing the efficiency of clinical trials. Stat Med. 1990;9(1\u20132):65\u201371.","journal-title":"Stat Med"},{"key":"406_CR15","doi-asserted-by":"publisher","first-page":"792","DOI":"10.1177\/0091270005277075","volume":"45","author":"CM Ng","year":"2005","unstructured":"Ng CM, Bruno R, Combs D, Davies B. Population pharmacokinetics of rituximab (anti-CD20 monoclonal antibody) in rheumatoid arthritis patients during a phase II clinical trial. J Clin Pharmacol. 2005;45:792\u2013801.","journal-title":"J Clin Pharmacol"},{"key":"406_CR16","doi-asserted-by":"publisher","first-page":"1773","DOI":"10.1111\/bcp.13270","volume":"83","author":"B Lioger","year":"2017","unstructured":"Lioger B, Edupuganti SR, Mulleman D, et al. Antigenic burden and serum IgG concentrations influence rituximab pharmacokinetics in rheumatoid arthritis patients. Br J Clin Pharmacol. 2017;83:1773\u201381.","journal-title":"Br J Clin Pharmacol"},{"issue":"119","key":"406_CR17","doi-asserted-by":"publisher","first-page":"3276","DOI":"10.1182\/blood-2011-09-380949","volume":"5","author":"C M\u00fcller","year":"2012","unstructured":"M\u00fcller C, Murawski N, Wiesen MH, et al. The role of sex and weight on rituximab clearance and serum elimination half-life in elderly patients with DLBCL. Blood. 2012;5(119):3276\u201384.","journal-title":"Blood"},{"key":"406_CR18","doi-asserted-by":"publisher","first-page":"934","DOI":"10.1080\/19420862.2018.1487912","volume":"10","author":"W Park","year":"2018","unstructured":"Park W, Bo\u017ei\u0107-Majstorovi\u0107 L, Milakovic D, et al. Comparison of biosimilar CT-P10 and innovator rituximab in patients with rheumatoid arthritis: a randomized controlled Phase 3 trial. MAbs. 2018;10:934\u201343.","journal-title":"MAbs."},{"key":"406_CR19","doi-asserted-by":"publisher","first-page":"566","DOI":"10.1136\/annrheumdis-2016-209540","volume":"76","author":"DH Yoo","year":"2017","unstructured":"Yoo DH, Suh CH, Shim SC, et al. A multicenter randomised controlled trial to compare the pharmacokinetics, efficacy and safety of CT-P10 and innovator rituximab in patients with rheumatoid arthritis. Ann Rheum Dis. 2017;76:566\u201370.","journal-title":"Ann Rheum Dis"},{"key":"406_CR20","doi-asserted-by":"publisher","first-page":"129","DOI":"10.1111\/bcp.12916","volume":"82","author":"S Cohen","year":"2016","unstructured":"Cohen S, Emery P, Greenwald M, et al. A phase I pharmacokinetics trial comparing PF-05280586 (a potential biosimilar) and rituximab in patients with active rheumatoid arthritis. Br J Clin Pharmacol. 2016;82:129\u201338.","journal-title":"Br J Clin Pharmacol"},{"key":"406_CR21","doi-asserted-by":"publisher","first-page":"1598","DOI":"10.1136\/annrheumdis-2017-211281","volume":"76","author":"JS Smolen","year":"2017","unstructured":"Smolen JS, Cohen SB, Tony HP, et al. A randomised, double-blind trial to demonstrate bioequivalence of GP2013 and reference rituximab combined with methotrexate in patients with active rheumatoid arthritis. Ann Rheum Dis. 2017;76:1598\u2013602.","journal-title":"Ann Rheum Dis"},{"key":"406_CR22","doi-asserted-by":"publisher","first-page":"2793","DOI":"10.1002\/art.22025","volume":"54","author":"SB Cohen","year":"2006","unstructured":"Cohen SB, Emery P, Greenwald MW, et al. Rituximab for rheumatoid arthritis refractory to anti-tumor necrosis factor therapy: results of a multicenter, randomized, double-blind, placebo-controlled, phase III trial evaluating primary efficacy and safety at twenty-four weeks. Arthritis Rheum. 2006;54:2793\u2013806.","journal-title":"Arthritis Rheum"},{"key":"406_CR23","doi-asserted-by":"publisher","first-page":"1390","DOI":"10.1002\/art.21778","volume":"54","author":"P Emery","year":"2006","unstructured":"Emery P, Fleischmann R, Filipowicz-Sosnowska A, et al. The efficacy and safety of rituximab in patients with active rheumatoid arthritis despite methotrexate treatment: results of a phase IIB randomized, double-blind, placebo-controlled, dose-ranging trial. Arthritis Rheum. 2006;54:1390\u2013400.","journal-title":"Arthritis Rheum"},{"key":"406_CR24","doi-asserted-by":"publisher","first-page":"2572","DOI":"10.1056\/NEJMoa032534","volume":"350","author":"JCW Edwards","year":"2004","unstructured":"Edwards JCW, Szczepanski L, Szechinski J, et al. Efficacy of B-cell targeted therapy with rituximab in patients with rheumatoid arthritis. N Engl J Med. 2004;350:2572\u201381.","journal-title":"N Engl J Med"},{"key":"406_CR25","doi-asserted-by":"publisher","first-page":"1629","DOI":"10.1136\/ard.2009.119933","volume":"69","author":"P Emery","year":"2010","unstructured":"Emery P, Deodhar A, Rigby WF, et al. Efficacy and safety of different doses and retreatment of rituximab: a randomised, placebo-controlled trial in patients who are biological naive with active rheumatoid arthritis and an inadequate response to methotrexate (Study Evaluating Rituximab\u2019s Efficacy in MTX iNadequate rEsponders (SERENE). Ann Rheum Dis. 2010;69:1629\u201335.","journal-title":"Ann Rheum Dis"},{"key":"406_CR26","doi-asserted-by":"publisher","first-page":"34","DOI":"10.1002\/art.1780390105","volume":"39","author":"AM van Gestel","year":"1996","unstructured":"van Gestel AM, Prevoo ML, van\u2019t Hof MA, van Rijswijk MH, van de Putte LB, van Riel PL. Development and validation of the European League Against Rheumatism response criteria for rheumatoid arthritis. Comparison with the preliminary American College of Rheumatology and the World Health Organization\/International League Against Rheumatism Criteria. Arthritis Rheum. 1996;39:34\u201340.","journal-title":"Arthritis Rheum"}],"container-title":["BioDrugs"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s40259-020-00406-1.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1007\/s40259-020-00406-1\/fulltext.html","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s40259-020-00406-1.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2021,8,10]],"date-time":"2021-08-10T17:32:45Z","timestamp":1628616765000},"score":1,"resource":{"primary":{"URL":"https:\/\/link.springer.com\/10.1007\/s40259-020-00406-1"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2020,2,12]]},"references-count":26,"journal-issue":{"issue":"2","published-print":{"date-parts":[[2020,4]]}},"alternative-id":["406"],"URL":"https:\/\/doi.org\/10.1007\/s40259-020-00406-1","relation":{},"ISSN":["1173-8804","1179-190X"],"issn-type":[{"value":"1173-8804","type":"print"},{"value":"1179-190X","type":"electronic"}],"subject":[],"published":{"date-parts":[[2020,2,12]]},"assertion":[{"value":"12 February 2020","order":1,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Compliance with Ethical Standards"}},{"value":"The study and the manuscript writing have been funded by Dr. Reddy\u2019s Laboratories.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Funding"}},{"value":"Luis Lopez-Lazaro, Sonica Sachdeva Batra, and Suresh Kankanwadi are employees of Dr. Reddy\u2019s Laboratories Ltd. Vikram Muralidhar Haridas, Rahul Katta, Ajit Nalawade; Sandeep Kharkar, Vyacheslav Zhdan, and Olena Garmish were the investigators involved in the study and have no conflicts of interest to disclose.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest"}}]}}