{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,4,9]],"date-time":"2025-04-09T01:26:24Z","timestamp":1744161984310,"version":"3.37.3"},"reference-count":82,"publisher":"Springer Science and Business Media LLC","issue":"4","license":[{"start":{"date-parts":[[2022,3,24]],"date-time":"2022-03-24T00:00:00Z","timestamp":1648080000000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.springer.com\/tdm"},{"start":{"date-parts":[[2022,3,24]],"date-time":"2022-03-24T00:00:00Z","timestamp":1648080000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/www.springer.com\/tdm"}],"funder":[{"DOI":"10.13039\/100010780","name":"Celltrion Healthcare","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100010780","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Clin Drug Investig"],"published-print":{"date-parts":[[2022,4]]},"DOI":"10.1007\/s40261-022-01133-x","type":"journal-article","created":{"date-parts":[[2022,3,24]],"date-time":"2022-03-24T22:03:52Z","timestamp":1648159432000},"page":"285-300","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["A Developer\u2019s Perspective on Clinical Evidence and Benefits for Rituximab Biosimilar Uptake, with a Focus on CT-P10"],"prefix":"10.1007","volume":"42","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-6280-3840","authenticated-orcid":false,"given":"Dasom","family":"Choi","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4798-2545","authenticated-orcid":false,"given":"Soohyun","family":"Lee","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9173-4047","authenticated-orcid":false,"given":"Seungmin","family":"Kim","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4690-6054","authenticated-orcid":false,"given":"Sangwook","family":"Yoon","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"297","published-online":{"date-parts":[[2022,3,24]]},"reference":[{"key":"1133_CR1","unstructured":"US Food and Drug Administration. Rituxan BLA approval letter. 1997. https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/appletter\/1997\/ritugen112697L.htm. Accessed 20 Jan 2022."},{"key":"1133_CR2","unstructured":"European Medicines Agency. MabThera scientific discussion. 2006. https:\/\/www.ema.europa.eu\/en\/documents\/scientific-discussion\/mabthera-epar-scientific-discussion_en.pdf. Accessed 20 Jan 2022."},{"key":"1133_CR3","unstructured":"European Medicines Agency. MabThera summary of product characteristics. 2021. https:\/\/www.ema.europa.eu\/en\/documents\/product-information\/mabthera-epar-product-information_en.pdf. Accessed 20 Jan 2022."},{"key":"1133_CR4","unstructured":"European Medicines Agency. Truxima summary of product characteristics. 2021. https:\/\/www.ema.europa.eu\/en\/documents\/product-information\/truxima-epar-product-information_en.pdf. Accessed 20 Jan 2022."},{"key":"1133_CR5","unstructured":"US Food and Drug Administration. Truxima BLA approval letter. 2018. https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/appletter\/2018\/761088Orig1s000ltr.pdf. Accessed 20 Jan 2022."},{"key":"1133_CR6","unstructured":"US Food and Drug Administration. Scientific considerations in demonstrating biosimilarity to a reference product. Guidance for industry. 2015. https:\/\/www.fda.gov\/media\/82647\/download. Accessed 20 Jan 2022."},{"key":"1133_CR7","unstructured":"European Medicines Agency. Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues (Revision 1). 2014. https:\/\/www.ema.europa.eu\/en\/documents\/scientific-guideline\/guideline-similar-biological-medicinal-products-containing-biotechnology-derived-proteins-active_en-2.pdf. Accessed 20 Jan 2022."},{"key":"1133_CR8","unstructured":"US Food and Drug Administration. Ruxience BLA approval letter. 2019. https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/appletter\/2019\/761103Orig1s000ltr.pdf. Accessed 20 Jan 2022."},{"key":"1133_CR9","unstructured":"US Food and Drug Administration. Riabni BLA approval letter. 2020. https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/appletter\/2020\/761140Orig1s000ltr.pdf. Accessed 20 Jan 2022."},{"key":"1133_CR10","unstructured":"European Medicines Agency. Ruxience summary of product characteristics. 2021. https:\/\/www.ema.europa.eu\/en\/documents\/product-information\/ruxience-epar-product-information_en.pdf. Accessed 20 Jan 2022."},{"key":"1133_CR11","unstructured":"European Medicines Agency. Riximyo summary of product characteristics. 2021. https:\/\/www.ema.europa.eu\/en\/documents\/product-information\/riximyo-epar-product-information_en.pdf. Accessed 20 Jan 2022."},{"key":"1133_CR12","unstructured":"European Medicines Agency. Rixathon summary of product characteristics. 2021. https:\/\/www.ema.europa.eu\/en\/documents\/product-information\/rixathon-epar-product-information_en.pdf. Accessed 20 Jan 2022."},{"key":"1133_CR13","unstructured":"European Medicines Agency. Blitzima summary of product characteristics. 2021. https:\/\/www.ema.europa.eu\/en\/documents\/product-information\/blitzima-epar-product-information_en.pdf. Accessed 20 Jan 2022."},{"issue":"3","key":"1133_CR14","doi-asserted-by":"crossref","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 multicentre 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(3):566\u201370.","journal-title":"Ann Rheum Dis"},{"issue":"4","key":"1133_CR15","doi-asserted-by":"crossref","first-page":"369","DOI":"10.1007\/s40259-017-0233-6","volume":"31","author":"W Park","year":"2017","unstructured":"Park W, Suh CH, Shim SC, et al. Efficacy and safety of switching from innovator rituximab to biosimilar CT-P10 compared with continued treatment with CT-P10: results of a 56-week open-label study in patients with rheumatoid arthritis. BioDrugs. 2017;31(4):369\u201377.","journal-title":"BioDrugs"},{"issue":"6","key":"1133_CR16","doi-asserted-by":"crossref","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(6):934\u201343.","journal-title":"MAbs"},{"issue":"11","key":"1133_CR17","doi-asserted-by":"crossref","first-page":"e543","DOI":"10.1016\/S2352-3026(18)30157-1","volume":"5","author":"M Ogura","year":"2018","unstructured":"Ogura M, Sancho JM, Cho SG, et al. Efficacy, pharmacokinetics, and safety of the biosimilar CT-P10 in comparison with rituximab in patients with previously untreated low-tumour-burden follicular lymphoma: a randomised, double-blind, parallel-group, phase 3 trial. Lancet Haematol. 2018;5(11):e543\u201353.","journal-title":"Lancet Haematol."},{"issue":"8","key":"1133_CR18","doi-asserted-by":"crossref","first-page":"e362","DOI":"10.1016\/S2352-3026(17)30120-5","volume":"4","author":"WS Kim","year":"2017","unstructured":"Kim WS, Buske C, Ogura M, et al. Efficacy, pharmacokinetics, and safety of the biosimilar CT-P10 compared with rituximab in patients with previously untreated advanced-stage follicular lymphoma: a randomised, double-blind, parallel-group, non-inferiority phase 3 trial. Lancet Haematol. 2017;4(8):e362\u201373.","journal-title":"Lancet Haematol."},{"issue":"1","key":"1133_CR19","doi-asserted-by":"crossref","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(1):129\u201338.","journal-title":"Br J Clin Pharmacol"},{"issue":"2","key":"1133_CR20","doi-asserted-by":"crossref","first-page":"171","DOI":"10.1007\/s40259-019-00398-7","volume":"34","author":"JP Sharman","year":"2020","unstructured":"Sharman JP, Liberati AM, Ishizawa K, et al. A randomized, double-blind, efficacy and safety study of PF-05280586 (a rituximab biosimilar) compared with rituximab reference product (MabThera\u00ae) in subjects with previously untreated CD20-positive, low-tumor-burden follicular lymphoma (LTB-FL). BioDrugs. 2020;34(2):171\u201381.","journal-title":"BioDrugs"},{"key":"1133_CR21","unstructured":"ClinicalTrials.gov. A study of PF-05280586 (rituximab-Pfizer) or MabThera\u00ae (rituximab-EU) for the first-line treatment of patients with CD20-positive, low tumor burden, follicular lymphoma (REFLECTIONS B328-06) (NCT02213263). 2019. https:\/\/www.clinicaltrials.gov\/ct2\/show\/NCT02213263. Accessed 20 Jan 2022."},{"issue":"5","key":"1133_CR22","doi-asserted-by":"crossref","first-page":"599","DOI":"10.1007\/s11523-020-00748-4","volume":"15","author":"D Niederwieser","year":"2020","unstructured":"Niederwieser D, Hamm C, Cobb P, et al. Efficacy and safety of ABP 798: results from the JASMINE trial in patients with follicular lymphoma in comparison with rituximab reference product. Target Oncol. 2020;15(5):599\u2013611.","journal-title":"Target Oncol"},{"key":"1133_CR23","unstructured":"ClinicalTrials.gov. Study to assess if ABP798 is safe & effective in treating non Hodgkin lymphoma compared to rituximab (JASMINE) (NCT02747043). 2020. https:\/\/www.clinicaltrials.gov\/ct2\/show\/NCT02747043. Accessed 20 Jan 2022."},{"issue":"8","key":"1133_CR24","doi-asserted-by":"crossref","first-page":"1003","DOI":"10.1002\/cpdd.845","volume":"9","author":"G Burmester","year":"2020","unstructured":"Burmester G, Chien D, Chow V, et al. A randomized, double-blind study comparing pharmacokinetics and pharmacodynamics of proposed biosimilar ABP 798 with rituximab reference product in subjects with moderate to severe rheumatoid arthritis. Clin Pharmacol Drug Dev. 2020;9(8):1003\u201314.","journal-title":"Clin Pharmacol Drug Dev."},{"issue":"11","key":"1133_CR25","doi-asserted-by":"crossref","first-page":"3341","DOI":"10.1007\/s10067-020-05305-y","volume":"39","author":"G Burmester","year":"2020","unstructured":"Burmester G, Drescher E, Hrycaj P, et al. Efficacy and safety results from a randomized double-blind study comparing proposed biosimilar ABP 798 with rituximab reference product in subjects with moderate-to-severe rheumatoid arthritis. Clin Rheumatol. 2020;39(11):3341\u201352.","journal-title":"Clin Rheumatol"},{"key":"1133_CR26","unstructured":"Amgen. Amgen and Allergan announce positive top-line results from phase 1\/ phase 3 study of ABP 798, biosimilar candidate to rituximab. 2019. https:\/\/www.amgen.com\/newsroom\/press-releases\/2019\/01\/amgen-and-allergan-announce-positive-topline-results-from-phase-1-phase-3-study-of-abp-798-biosimilar-candidate-to-rituximab. Accessed 20 Jan 2022."},{"issue":"8","key":"1133_CR27","doi-asserted-by":"crossref","first-page":"e350","DOI":"10.1016\/S2352-3026(17)30106-0","volume":"4","author":"W Jurczak","year":"2017","unstructured":"Jurczak W, Moreira I, Kanakasetty GB, et al. Rituximab biosimilar and reference rituximab in patients with previously untreated advanced follicular lymphoma (ASSIST-FL): primary results from a confirmatory phase 3, double-blind, randomised, controlled study. Lancet Haematol. 2017;4(8):e350\u201361.","journal-title":"Lancet Haematol."},{"issue":"9","key":"1133_CR28","doi-asserted-by":"crossref","first-page":"1598","DOI":"10.1136\/annrheumdis-2017-211281","volume":"76","author":"JS Smolen","year":"2017","unstructured":"Smolen JS, Cohen SB, Tony H-P, 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(9):1598\u2013602.","journal-title":"Ann Rheum Dis"},{"key":"1133_CR29","unstructured":"ClinicalTrials.gov. GP2013 in the treatment of RA patients refractory to or intolerant of standard therapy. 2018. https:\/\/clinicaltrials.gov\/ct2\/show\/NCT01274182. Accessed 20 Jan 2022."},{"key":"1133_CR30","unstructured":"US Food and Drug Administration. Truxima prescribing information. 2020. https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2020\/761088s009lbl.pdf. Accessed 20 Jan 2022."},{"key":"1133_CR31","unstructured":"US Food and Drug Administration. Riabni prescribing information. 2020. https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2020\/761140s000lbl.pdf. Accessed 20 Jan 2022."},{"issue":"12","key":"1133_CR32","doi-asserted-by":"crossref","first-page":"2193","DOI":"10.1093\/rheumatology\/kez152","volume":"58","author":"SC Shim","year":"2019","unstructured":"Shim SC, Bo\u017ei\u0107-Majstorovi\u0107 L, Berrocal Kasay A, et al. Efficacy and safety of switching from rituximab to biosimilar CT-P10 in rheumatoid arthritis: 72-week data from a randomized phase 3 trial. Rheumatology. 2019;58(12):2193\u2013202.","journal-title":"Rheumatology"},{"issue":"17","key":"1133_CR33","doi-asserted-by":"crossref","first-page":"3354","DOI":"10.1182\/bloodadvances.2021004484","volume":"5","author":"C Buske","year":"2021","unstructured":"Buske C, Jurczak W, Sancho JM, et al. Long-term efficacy and safety of CT-P10 or rituximab in untreated advanced follicular lymphoma: a randomized phase 3 study. Blood Adv. 2021;5(17):3354\u201361.","journal-title":"Blood Adv"},{"key":"1133_CR34","doi-asserted-by":"publisher","DOI":"10.1016\/j.clml.2021.08.005","author":"LW Kwak","year":"2021","unstructured":"Kwak LW, Sancho J-M, Cho S-G, et al. Efficacy and safety of CT-P10 versus rituximab in untreated low-tumour-burden follicular lymphoma: final results of a randomised phase 3 study. Clin Lymphoma Myeloma Leuk. 2021. https:\/\/doi.org\/10.1016\/j.clml.2021.08.005.","journal-title":"Clin Lymphoma Myeloma Leuk"},{"issue":"11","key":"1133_CR35","doi-asserted-by":"crossref","first-page":"1598","DOI":"10.1002\/acr.23586","volume":"70","author":"SB Cohen","year":"2018","unstructured":"Cohen SB, Burgos-Vargas R, Emery P, et al. Extension study of PF-05280586, a potential rituximab biosimilar, versus rituximab in subjects with active rheumatoid arthritis. Arthritis Care Res. 2018;70(11):1598\u2013606.","journal-title":"Arthritis Care Res"},{"issue":"1","key":"1133_CR36","doi-asserted-by":"crossref","first-page":"256","DOI":"10.1093\/rheumatology\/keaa234","volume":"60","author":"JS Smolen","year":"2021","unstructured":"Smolen JS, Cohen SB, Tony HP, et al. Efficacy and safety of Sandoz biosimilar rituximab for active rheumatoid arthritis: 52-week results from the randomized controlled ASSIST-RA trial. Rheumatology. 2021;60(1):256\u201362.","journal-title":"Rheumatology"},{"key":"1133_CR37","doi-asserted-by":"crossref","first-page":"v355","DOI":"10.1093\/annonc\/mdx373","volume":"28","author":"W Jurczak","year":"2017","unstructured":"Jurczak W, Moreira I, Setty Govindbabu K, et al. Equivalent efficacy of a biosimilar rituximab and reference rituximab in previously untreated advanced follicular lymphoma: extended results of ASSIST-FL, a confirmatory phase III study. Ann Oncol. 2017;28:v355.","journal-title":"Ann Oncol"},{"issue":"1","key":"1133_CR38","doi-asserted-by":"crossref","first-page":"88","DOI":"10.1002\/acr.23771","volume":"71","author":"HP Tony","year":"2019","unstructured":"Tony HP, Kr\u00fcger K, Cohen SB, et al. Brief report: safety and immunogenicity of rituximab biosimilar GP 2013 after switch from reference rituximab in patients with active rheumatoid arthritis. Arthritis Care Res. 2019;71(1):88\u201394.","journal-title":"Arthritis Care Res"},{"key":"1133_CR39","unstructured":"ClinicalTrials.gov. GP2013 treatment in patients with active rheumatoid arthritis, previously treated with Rituxan\u00ae or MabThera\u00ae (ASSIST-RT) (NCT02514772). 2017. https:\/\/clinicaltrials.gov\/ct2\/show\/NCT02514772. Accessed 20 Jan 2022."},{"key":"1133_CR40","unstructured":"US Food and Drug Administration. Ruxience prescribing information. 2021. https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2021\/761103s005lbl.pdf. Accessed 20 Jan 2022."},{"key":"1133_CR41","unstructured":"European Medicines Agency. Rituzena withdrawal of the marketing authorisation in the European Union. 2019. https:\/\/www.ema.europa.eu\/en\/documents\/public-statement\/public-statement-rituzena-withdrawal-marketing-authorisation-european-union_en.pdf. Accessed 20 Jan 2022."},{"key":"1133_CR42","unstructured":"European Medicines Agency. Ritemvia withdrawal of the marketing authorisation in the European Union. 2021. https:\/\/www.ema.europa.eu\/en\/documents\/public-statement\/public-statement-ritemvia-withdrawal-marketing-authorisation-european-union_en.pdf. Accessed 20 Jan 2022."},{"key":"1133_CR43","unstructured":"Generics and Biosimilar Initiative. Boehringer Ingelheim and Sandoz abandon biosimilars. 2018. https:\/\/www.gabionline.net\/biosimilars\/general\/Boehringer-Ingelheim-and-Sandoz-abandon-biosimilars. Accessed 20 Jan 2022."},{"key":"1133_CR44","unstructured":"US Food and Drug Administration. Rituxan prescribing information. 2021. https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2021\/103705s5467lbl.pdf. Accessed 20 Jan 2022."},{"issue":"26","key":"1133_CR45","doi-asserted-by":"crossref","first-page":"2017","DOI":"10.2217\/fon-2020-0131","volume":"16","author":"P Nava-Parada","year":"2020","unstructured":"Nava-Parada P, Shelbaya A, Nabhan C. Rituximab biosimilars in hematologic malignancies: the need for a real-world approach. Future Oncol. 2020;16(26):2017\u201327.","journal-title":"Future Oncol"},{"issue":"6","key":"1133_CR46","doi-asserted-by":"crossref","first-page":"e323","DOI":"10.1097\/HS9.0000000000000323","volume":"3","author":"J Gribben","year":"2019","unstructured":"Gribben J, Merlini G, Hagenbeek A, et al. Here to stay: biosimilars in hematology. HemaSphere. 2019;3(6):e323.","journal-title":"HemaSphere."},{"key":"1133_CR47","unstructured":"National Comprehensive Cancer Center. B-cell lymphomas. Version 5.2021. https:\/\/www.nccn.org\/professionals\/physician_gls\/pdf\/b-cell.pdf. Accessed 20 Jan 2022."},{"issue":"12","key":"1133_CR48","doi-asserted-by":"crossref","first-page":"1260","DOI":"10.1200\/JCO.2017.77.4893","volume":"36","author":"GH Lyman","year":"2018","unstructured":"Lyman GH, Balaban E, Diaz M, et al. American Society of Clinical Oncology statement: biosimilars in oncology. J Clin Oncol. 2018;36(12):1260\u20135.","journal-title":"J Clin Oncol"},{"issue":"6","key":"1133_CR49","doi-asserted-by":"crossref","first-page":"e000142","DOI":"10.1136\/esmoopen-2016-000142","volume":"1","author":"J Tabernero","year":"2016","unstructured":"Tabernero J, Vyas M, Giuliani R, et al. Biosimilars: a position paper of the European Society for Medical Oncology, with particular reference to oncology prescribers. ESMO Open. 2016;1(6):e000142.","journal-title":"ESMO Open."},{"issue":"1","key":"1133_CR50","doi-asserted-by":"crossref","first-page":"79","DOI":"10.1007\/s40259-018-00331-4","volume":"33","author":"C-H Suh","year":"2019","unstructured":"Suh C-H, Yoo DH, Berrocal Kasay A, et al. Long-term efficacy and safety of biosimilar CT-P10 versus innovator rituximab in rheumatoid arthritis: 48-week results from a randomized phase III trial. BioDrugs. 2019;33(1):79\u201391.","journal-title":"BioDrugs"},{"key":"1133_CR51","unstructured":"Buske C, Kwak LW, Kim WS, et al. Safety profile of rituximab biosimilar CT-P10 in follicular lymphoma: a pooled analysis of final data from CT-P10 phase 3 follicular lymphoma studies [abstract EP1198]. 2020. https:\/\/library.ehaweb.org\/eha\/2020\/eha25th\/293688\/. Accessed 20 Jan 2022."},{"issue":"7","key":"1133_CR52","doi-asserted-by":"crossref","first-page":"1575","DOI":"10.1080\/10428194.2020.1742906","volume":"61","author":"K Lee","year":"2020","unstructured":"Lee K, Ha JY, Jung AR, et al. The clinical outcomes of rituximab biosimilar CT-P10 (Truxima\u00ae) with CHOP as first-line treatment for patients with diffuse large B-cell lymphoma: real-world experience. Leuk Lymphoma. 2020;61(7):1575\u201383.","journal-title":"Leuk Lymphoma"},{"key":"1133_CR53","unstructured":"Bishton M, Laribi K, Salles G, et al. Real world clinical effectiveness and safety of CT-P10 in patients with diffuse large B-cell lymphoma: results from a European non-interventional post authorization safety study [abstract EP529]. 2021. https:\/\/library.ehaweb.org\/eha\/2021\/eha2021-virtual-congress\/325289\/mark.bishton.real.world.clinical.effectiveness.and.safety.of.ct-p10.in.html. Accessed 20 Jan 2022."},{"issue":"15","key":"1133_CR54","doi-asserted-by":"crossref","first-page":"2958","DOI":"10.1182\/bloodadvances.2021004295","volume":"5","author":"M Brink","year":"2021","unstructured":"Brink M, Kahle XU, Vermaat JSP, et al. Impact of rituximab biosimilars on overall survival in diffuse large B-cell lymphoma: a Dutch population-based study. Blood Adv. 2021;5(15):2958\u201364.","journal-title":"Blood Adv"},{"issue":"6","key":"1133_CR55","doi-asserted-by":"crossref","first-page":"1432","DOI":"10.1177\/1078155220957079","volume":"27","author":"D Mendes","year":"2021","unstructured":"Mendes D, Abrantes J, Rigueiro G, et al. Real-world intensive safety monitoring of biosimilars rituximab and trastuzumab in a Portuguese oncology hospital. J Oncol Pharm Pract. 2021;27(6):1432\u20138.","journal-title":"J Oncol Pharm Pract"},{"issue":"1","key":"1133_CR56","doi-asserted-by":"crossref","first-page":"5956","DOI":"10.1038\/s41598-021-85563-1","volume":"11","author":"SAM Urru","year":"2021","unstructured":"Urru SAM, Spila Alegiani S, Guella A, et al. Safety of switching between rituximab biosimilars in onco-hematology. Sci Rep. 2021;11(1):5956.","journal-title":"Sci Rep"},{"issue":"8","key":"1133_CR57","doi-asserted-by":"crossref","first-page":"712","DOI":"10.3349\/ymj.2020.61.8.712","volume":"61","author":"HC Kwon","year":"2020","unstructured":"Kwon HC, Kim MK, Song JJ, et al. Rituximab biosimilar prevents poor outcomes of microscopic polyangiitis and granulomatosis with polyangiitis as effectively as rituximab originator. Yonsei Med J. 2020;61(8):712\u20139.","journal-title":"Yonsei Med J"},{"issue":"5","key":"1133_CR58","doi-asserted-by":"crossref","first-page":"912","DOI":"10.1111\/bjh.15874","volume":"185","author":"MJ Stubbs","year":"2019","unstructured":"Stubbs MJ, Low R, McGuckin S, et al. Comparison of rituximab originator (MabThera) to biosimilar (Truxima) in patients with immune-mediated thrombotic thrombocytopenic purpura. Br J Haematol. 2019;185(5):912\u20137.","journal-title":"Br J Haematol"},{"issue":"Suppl 1","key":"1133_CR59","first-page":"163","volume":"181","author":"SGH Kundu","year":"2018","unstructured":"Kundu SGH. Single hospital retrospective review of the use of monoclonal antibody and its biosimilar Truxima in chronic immune thrombocytopenia. Br J Haematol. 2018;181(Suppl 1):163.","journal-title":"Br J Haematol"},{"key":"1133_CR60","doi-asserted-by":"crossref","first-page":"63","DOI":"10.1016\/j.ejim.2020.12.006","volume":"84","author":"E Della-Torre","year":"2021","unstructured":"Della-Torre E, Lanzillotta M, Campochiaro C, et al. Efficacy and safety of rituximab biosimilar (CT-P10) in IgG4-related disease: an observational prospective open-label cohort study. Eur J Intern Med. 2021;84:63\u20137.","journal-title":"Eur J Intern Med"},{"issue":"4","key":"1133_CR61","doi-asserted-by":"crossref","first-page":"585","DOI":"10.1177\/1352458520912170","volume":"27","author":"T Perez","year":"2021","unstructured":"Perez T, Rico A, Bouti\u00e8re C, et al. Comparison of rituximab originator (MabThera\u00ae) to biosimilar (Truxima\u00ae) in patients with multiple sclerosis. Mult Scler. 2021;27(4):585\u201392.","journal-title":"Mult Scler"},{"issue":"1","key":"1133_CR62","doi-asserted-by":"crossref","first-page":"149","DOI":"10.1007\/s11739-020-02386-0","volume":"16","author":"C Vacchi","year":"2021","unstructured":"Vacchi C, Visentini M, Gragnani L, et al. Safety and effectiveness of biosimilar of Rituximab CT-P10 in the treatment of cryoglobulinemic vasculitis: the MARBLe study (Mixed cryoglobulinemiA Rituximab BiosimiLar). Intern Emerg Med. 2021;16(1):149\u201356.","journal-title":"Intern Emerg Med"},{"issue":"2","key":"1133_CR63","doi-asserted-by":"crossref","first-page":"135","DOI":"10.1080\/03009742.2021.1926318","volume":"51","author":"M Antonelou","year":"2022","unstructured":"Antonelou M, Abro A, Heath R, et al. Comparison of outcomes using the rituximab originator MabThera with the biosimilar Truxima in patients with ANCA-associated vasculitis. Scand J Rheumatol. 2022;51(2):135\u201341.","journal-title":"Scand J Rheumatol."},{"issue":"12","key":"1133_CR64","doi-asserted-by":"crossref","first-page":"3731","DOI":"10.1093\/rheumatology\/keaa136","volume":"59","author":"C Campochiaro","year":"2020","unstructured":"Campochiaro C, De Luca G, Lazzaroni MG, et al. Safety and efficacy of rituximab biosimilar (CT-P10) in systemic sclerosis: an Italian multicentre study. Rheumatology. 2020;59(12):3731\u20136.","journal-title":"Rheumatology"},{"key":"1133_CR65","doi-asserted-by":"crossref","first-page":"534","DOI":"10.3389\/fmed.2020.00534","volume":"7","author":"V Pavlych","year":"2020","unstructured":"Pavlych V, Di Muzio C, Alunno A, et al. Comparison of rituximab originator with CT-P10 biosimilar in patients with primary Sj\u00f6gren\u2019s syndrome: a retrospective analysis in a real-life setting. Front Med. 2020;7:534.","journal-title":"Front Med"},{"issue":"1","key":"1133_CR66","doi-asserted-by":"crossref","first-page":"e000442","DOI":"10.1136\/lupus-2020-000442","volume":"7","author":"N Pongtarakulpanit","year":"2020","unstructured":"Pongtarakulpanit N, Pisitkun P, Ngamjanyaporn P. Efficacy and safety of rituximab biosimilar in refractory lupus. Lupus Sci Med. 2020;7(1):e000442.","journal-title":"Lupus Sci Med."},{"issue":"Suppl 2","key":"1133_CR67","doi-asserted-by":"crossref","first-page":"538","DOI":"10.1002\/hon.224_2631","volume":"37","author":"M Bishton","year":"2019","unstructured":"Bishton M, Marshall SR, Conteh V, et al. CT-P10 rapid infusion in patients with non-Hodgkin\u2019s lymphoma or chronic lymphocytic leukaemia: interim results from a non-interventional post-authorisation study [abstract\/poster]. Hematol Oncol. 2019;37(Suppl 2):538\u20139.","journal-title":"Hematol Oncol"},{"issue":"8","key":"1133_CR68","first-page":"58","volume":"23","author":"C Polwart","year":"2017","unstructured":"Polwart C. Using meta-analysis to develop an audit standard for the rapid infusion of bio-similar rituximab. J Oncol Pharm Pract. 2017;23(8):58\u20139.","journal-title":"J Oncol Pharm Pract"},{"issue":"Suppl 1","key":"1133_CR69","first-page":"3387","volume":"130","author":"R Shah","year":"2017","unstructured":"Shah R, Cheesman S, Ardeshna KM, et al. Evaluation of the safety and tolerability of rapid infusion of biosimilar rituximab Truxima\u00ae\u2014the University College London Hospitals (UCLH) experience. Blood. 2017;130(Suppl 1):3387.","journal-title":"Blood"},{"issue":"15","key":"1133_CR70","doi-asserted-by":"crossref","first-page":"1609","DOI":"10.1007\/s40265-019-01193-y","volume":"79","author":"PL Zinzani","year":"2019","unstructured":"Zinzani PL, Dreyling M, Gradishar W, et al. Are biosimilars the future of oncology and haematology? Drugs. 2019;79(15):1609\u201324.","journal-title":"Drugs"},{"key":"1133_CR71","unstructured":"Koh Y, Park C, Byun J, et al. Rituximab, lenalidomide and acalabrutinib (R2A) for relapsed\/refractory aggressive B-cell lymphoma: interim analysis reporting good tolerability and potential durable response [abstract\/poster EP1272]. 2020. https:\/\/library.ehaweb.org\/eha\/2020\/eha25th\/293761\/youngil.koh.rituximab.lenalidomide.and.acalabrutinib.28r2a29.for.relapsed.html. Accessed 20 Jan 2022."},{"issue":"1","key":"1133_CR72","doi-asserted-by":"crossref","first-page":"749","DOI":"10.1186\/s12885-021-08464-6","volume":"21","author":"A Grunenberg","year":"2021","unstructured":"Grunenberg A, Kaiser LM, Woelfle S, et al. A phase II study of the PI3K inhibitor copanlisib in combination with the anti-CD20 monoclonal antibody rituximab for patients with marginal zone lymphoma: treatment rationale and protocol design of the COUP-1 trial. BMC Cancer. 2021;21(1):749.","journal-title":"BMC Cancer"},{"issue":"2","key":"1133_CR73","doi-asserted-by":"crossref","first-page":"241","DOI":"10.1001\/jamaoncol.2017.2004","volume":"4","author":"C Nabhan","year":"2018","unstructured":"Nabhan C, Parsad S, Mato AR, et al. Biosimilars in oncology in the United States: a review. JAMA Oncol. 2018;4(2):241\u20137.","journal-title":"JAMA Oncol"},{"issue":"2","key":"1133_CR74","doi-asserted-by":"crossref","first-page":"159","DOI":"10.1007\/s40259-019-00395-w","volume":"34","author":"B Dutta","year":"2020","unstructured":"Dutta B, Huys I, Vulto AG, et al. Identifying key benefits in European off-patent biologics and biosimilar markets: it is not only about price! BioDrugs. 2020;34(2):159\u201370.","journal-title":"BioDrugs"},{"issue":"6","key":"1133_CR75","doi-asserted-by":"crossref","first-page":"e322","DOI":"10.1097\/HS9.0000000000000322","volume":"3","author":"AG Vulto","year":"2019","unstructured":"Vulto AG. Biologicals and biosimilars in hematology: the case of rituximab. HemaSphere. 2019;3(6):e322.","journal-title":"HemaSphere."},{"key":"1133_CR76","unstructured":"European Alliance of Associations for Rheumatology. Biosimilars\u2014position paper. Updating position statement from the European League Against Rheumatism (EULAR) standing committee of People with Arthritis\/Rheumatism in Europe (PARE) 2018. https:\/\/www.eular.org\/myUploadData\/files\/biosimilars_paper_updated_2018_09_14_dw.pdf. Accessed 20 Jan 2022."},{"issue":"5","key":"1133_CR77","doi-asserted-by":"crossref","first-page":"1128","DOI":"10.1007\/s12325-017-0522-y","volume":"34","author":"L Gul\u00e1csi","year":"2017","unstructured":"Gul\u00e1csi L, Brodszky V, Baji P, et al. The rituximab biosimilar CT-P10 in rheumatology and cancer: a budget impact analysis in 28 European countries. Adv Ther. 2017;34(5):1128\u201344.","journal-title":"Adv Ther"},{"issue":"1","key":"1133_CR78","doi-asserted-by":"crossref","first-page":"89","DOI":"10.1007\/s40259-020-00461-8","volume":"35","author":"M Jang","year":"2021","unstructured":"Jang M, Simoens S, Kwon T. Budget impact analysis of the introduction of rituximab and trastuzumab intravenous biosimilars to EU-5 markets. BioDrugs. 2021;35(1):89\u2013101.","journal-title":"BioDrugs"},{"key":"1133_CR79","doi-asserted-by":"crossref","first-page":"527","DOI":"10.2147\/CEOR.S265041","volume":"12","author":"A Almaaytah","year":"2020","unstructured":"Almaaytah A. Budget impact analysis of switching to rituximab\u2019s biosimilar in rheumatology and cancer in 13 countries within the Middle East and North Africa. Clinicoecon Outcomes Res. 2020;12:527\u201334.","journal-title":"Clinicoecon Outcomes Res."},{"issue":"5","key":"1133_CR80","doi-asserted-by":"crossref","first-page":"261","DOI":"10.1002\/acr2.11133","volume":"2","author":"ZS Wallace","year":"2020","unstructured":"Wallace ZS, Harkness T, Blumenthal KG, et al. Increasing operational capacity and reducing costs of rituximab administration: a costing analysis. ACR Open Rheumatol. 2020;2(5):261\u20138.","journal-title":"ACR Open Rheumatol."},{"issue":"1","key":"1133_CR81","doi-asserted-by":"crossref","first-page":"e515","DOI":"10.1097\/HS9.0000000000000515","volume":"5","author":"S Cheesman","year":"2021","unstructured":"Cheesman S. Introduction of biosimilar rituximab: a hospital perspective. HemaSphere. 2021;5(1):e515.","journal-title":"HemaSphere."},{"issue":"2","key":"1133_CR82","doi-asserted-by":"crossref","first-page":"99","DOI":"10.1007\/s40265-020-01256-5","volume":"80","author":"H Kim","year":"2020","unstructured":"Kim H, Alten R, Avedano L, et al. The future of biosimilars: maximizing benefits across immune-mediated inflammatory diseases. Drugs. 2020;80(2):99\u2013113.","journal-title":"Drugs"}],"container-title":["Clinical Drug Investigation"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s40261-022-01133-x.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1007\/s40261-022-01133-x\/fulltext.html","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s40261-022-01133-x.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2022,4,7]],"date-time":"2022-04-07T14:52:11Z","timestamp":1649343131000},"score":1,"resource":{"primary":{"URL":"https:\/\/link.springer.com\/10.1007\/s40261-022-01133-x"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2022,3,24]]},"references-count":82,"journal-issue":{"issue":"4","published-print":{"date-parts":[[2022,4]]}},"alternative-id":["1133"],"URL":"https:\/\/doi.org\/10.1007\/s40261-022-01133-x","relation":{},"ISSN":["1173-2563","1179-1918"],"issn-type":[{"type":"print","value":"1173-2563"},{"type":"electronic","value":"1179-1918"}],"subject":[],"published":{"date-parts":[[2022,3,24]]},"assertion":[{"value":"13 February 2022","order":1,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"24 March 2022","order":2,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"Medical writing support for this work was funded by Celltrion Healthcare Co., Ltd (Incheon, Republic of Korea).","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Funding"}},{"value":"All authors are employees of Celltrion Healthcare and have no other interests to disclose.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest"}},{"value":"Not applicable.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval"}},{"value":"Not applicable.","order":5,"name":"Ethics","group":{"name":"EthicsHeading","label":"Availability of data and material"}},{"value":"Not applicable.","order":6,"name":"Ethics","group":{"name":"EthicsHeading","label":"Code availability"}},{"value":"Not applicable.","order":7,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent to participate"}},{"value":"Not applicable.","order":8,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"All authors participated in the writing of the paper, reviewed the manuscript, and approved the final version for submission.","order":9,"name":"Ethics","group":{"name":"EthicsHeading","label":"Author contributions"}}]}}