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It is therefore used in the treatment of moderate to severe rheumatoid arthritis in patients with inadequate response to antirheumatic drugs, and in the treatment of systemic juvenile idiopathic arthritis. During the course of the Coronavirus Disease 2019 (COVID\u201019) pandemic, the potential application of Tocilizumab in severe inflammatory diseases was demonstrated. In addition, the drug is attracting increasing attention for its potential application in other pathologies, particularly cancers where the central role of Interleukin 6 (IL\u20106) has been described, such as pancreatic ductal adenocarcinoma. The necessity for further research in this area is far too great, which is why the development of additional biosimilars is both necessary and welcome. In this work, we describe the generation and biological characterization of a biosimilar candidate of Tocilizumab. A stable producing CHO\u2010K1 cell line was obtained by lentiviral transduction. We demonstrated that the antibody generated, named 41TB, has similar size heterogeneity and electrophoretic profile as Tocilizumab, and high levels of purity. Moreover, 41TB exhibits comparable binding capacity to IL\u20106R\u03b1, as well as the ability to interrupt IL\u20106\/IL\u20106R\u03b1 binding in ELISA. Additionally, both antibodies were likewise able to inhibit DS\u20101 cell proliferation, IL\u20106 induced STAT3 phosphorylation, and C\u2010Reactive Protein production in vitro. Galactose supplementation of the culture medium appears to be necessary to generate a glycosylation profile similar to the original antibody.<\/jats:p>","DOI":"10.1002\/biot.70017","type":"journal-article","created":{"date-parts":[[2025,6,17]],"date-time":"2025-06-17T01:02:43Z","timestamp":1750122163000},"source":"Crossref","is-referenced-by-count":3,"title":["Generation and Biological Characterization of an Anti\u2010IL\u20106R\u03b1 Biosimilar Candidate Antibody"],"prefix":"10.1002","volume":"20","author":[{"given":"Gisela","family":"Garc\u00eda\u2010P\u00e9rez","sequence":"first","affiliation":[{"name":"Immune Regulation Department Immunology and Immunotherapy Direction Center of Molecular Immunology  Havana Cuba"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gabriela","family":"Garc\u00eda\u2010Entenza","sequence":"additional","affiliation":[{"name":"Bioprocess R&amp;D Direction Center of Molecular Immunology  Havana Cuba"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Arlem Garc\u00eda","family":"Delgado","sequence":"additional","affiliation":[{"name":"Immune Regulation Department Immunology and Immunotherapy Direction Center of Molecular Immunology  Havana Cuba"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Arnelys","family":"Dur\u00e1n\u2010Hern\u00e1ndez","sequence":"additional","affiliation":[{"name":"Bioprocess R&amp;D Direction Center of Molecular Immunology  Havana Cuba"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5366-0035","authenticated-orcid":false,"given":"Tania G\u00f3mez","family":"Pe\u00f1a","sequence":"additional","affiliation":[{"name":"Quality Direction Center of Molecular Immunology  Havana Cuba"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Roberto Daniel","family":"Machado\u2010Santisteban","sequence":"additional","affiliation":[{"name":"Bioprocess R&amp;D Direction Center of Molecular Immunology  Havana Cuba"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gertrudis","family":"Rojas","sequence":"additional","affiliation":[{"name":"Protein Engineering Department Immunology and Immunotherapy Direction Center of Molecular Immunology  Havana Cuba"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tania","family":"Carmenate","sequence":"additional","affiliation":[{"name":"Immune Regulation Department Immunology and Immunotherapy Direction Center of Molecular Immunology  Havana Cuba"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2025,6,16]]},"reference":[{"key":"e_1_2_10_2_1","doi-asserted-by":"publisher","DOI":"10.2165\/11635830-000000000-00000"},{"key":"e_1_2_10_3_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.dmpk.2018.11.004"},{"key":"e_1_2_10_4_1","doi-asserted-by":"publisher","DOI":"10.1002\/pds.4809"},{"key":"e_1_2_10_5_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00253\u2010016\u20107388\u20109"},{"key":"e_1_2_10_6_1","doi-asserted-by":"publisher","DOI":"10.1038\/nbt.3040"},{"key":"e_1_2_10_7_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.semarthrit.2015.04.002"},{"key":"e_1_2_10_8_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40259\u2010016\u20100207\u20100"},{"issue":"4","key":"e_1_2_10_9_1","first-page":"851","article-title":"Reshaping a human Antibody to Inhibit the Interleukin 6\u2010Dependent Tumor Cell Growth","volume":"53","author":"Sato K.","year":"1993","journal-title":"Cancer Research"},{"key":"e_1_2_10_10_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.intimp.2005.05.010"},{"key":"e_1_2_10_11_1","doi-asserted-by":"publisher","DOI":"10.2147\/OARRR.S17118"},{"key":"e_1_2_10_12_1","doi-asserted-by":"publisher","DOI":"10.1007\/s12272\u2010015\u20100569\u20108"},{"key":"e_1_2_10_13_1","doi-asserted-by":"publisher","DOI":"10.1038\/nrd.2018.45"},{"key":"e_1_2_10_14_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140\u20106736(21)00676\u20100"},{"key":"e_1_2_10_15_1","doi-asserted-by":"publisher","DOI":"10.1038\/s41573\u2010023\u201000672\u2010y"},{"key":"e_1_2_10_16_1","doi-asserted-by":"publisher","DOI":"10.2147\/TCRM.S223468"},{"key":"e_1_2_10_17_1","doi-asserted-by":"publisher","DOI":"10.3389\/fimmu.2022.807050"},{"key":"e_1_2_10_18_1","doi-asserted-by":"publisher","DOI":"10.3390\/cells10081928"},{"key":"e_1_2_10_19_1","doi-asserted-by":"publisher","DOI":"10.1002\/mc.23234"},{"key":"e_1_2_10_20_1","doi-asserted-by":"publisher","DOI":"10.3892\/ijo.2015.2851"},{"key":"e_1_2_10_21_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.imbio.2011.07.004"},{"key":"e_1_2_10_22_1","doi-asserted-by":"publisher","DOI":"10.4161\/mabs.20761"},{"key":"e_1_2_10_23_1","doi-asserted-by":"publisher","DOI":"10.1186\/1472\u20106750\u201013\u201052"},{"key":"e_1_2_10_24_1","unstructured":"M.Tsuchiya K.Sato M. 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