3,934
Views
37
CrossRef citations to date
0
Altmetric
Research Article

Target-directed development and preclinical characterization of the proposed biosimilar rituximab GP2013

, , , , , , , & show all
Pages 1609-1617 | Received 03 Jul 2013, Accepted 06 Sep 2013, Published online: 24 Jan 2014

Keep up to date with the latest research on this topic with citation updates for this article.

Read on this site (5)

Anurag Rathore & Himanshu Malani. (2022) Need for a risk-based control strategy for managing glycosylation profile for biosimilar products. Expert Opinion on Biological Therapy 22:2, pages 123-131.
Read now
Wojciech Jurczak, Monika Długosz Danecka & Christian Buske. (2019) Rituximab biosimilars for lymphoma in Europe. Expert Opinion on Biological Therapy 19:10, pages 1045-1056.
Read now
Sanjay Kumar Singh, Santosh Pokalwar, Sandip Bose, Shivika Gupta, Suhani Almal & Ranjit Sudhakar Ranbhor. (2018) Structural and functional comparability study of anti-CD20 monoclonal antibody with reference product. Biologics: Targets and Therapy 12, pages 159-170.
Read now
Neh Nupur, Nidhi Chhabra, Rozaleen Dash & Anurag S. Rathore. (2018) Assessment of structural and functional similarity of biosimilar products: Rituximab as a case study. mAbs 10:1, pages 143-158.
Read now
Sanjay Bandyopadhyay, Mukesh Mahajan, Tulsi Mehta, Arun K Singh, Aashini Parikh, Ajit K Gupta, Pankaj Kalita, Mihir Patel & Sanjeev Kumar Mendiratta. (2015) Physicochemical and functional characterization of a biosimilar adalimumab ZRC-3197. Biosimilars 5, pages 1-18.
Read now

Articles from other publishers (32)

Silvia Millán-Martín, Craig Jakes, Sara Carillo & Jonathan Bones. (2023) Multi-attribute method (MAM) to assess analytical comparability of adalimumab biosimilars. Journal of Pharmaceutical and Biomedical Analysis 234, pages 115543.
Crossref
Manfred Welslau, Boris Kubuschok, Julian Topaly, Burkhard Otremba, Thomas Wolff & Galyna Bryn. (2023) REFLECT: prospective multicenter non-interventional study evaluating the effectiveness and safety of Sandoz rituximab (SDZ-RTX; Rixathon ® ) in combination with CHOP for the treatment of patients with previously untreated CD20-positive diffuse large B-cell lymphoma . Therapeutic Advances in Hematology 14.
Crossref
Paola Karp, Matías Gatto, María Victoria Batto, Sol Ferrero & Gustavo Helguera. 2022. Biosimilars. Biosimilars.
Rozaleen Dash, Sumit Kumar Singh, Narendra Chirmule & Anurag S. Rathore. (2021) Assessment of Functional Characterization and Comparability of Biotherapeutics: a Review. The AAPS Journal 24:1.
Crossref
Tejinder Kaur, Bhupendra Nath Shukla, Vinay Kumar Yadav, Mahesh J. Kulkarni & Alka Rao. (2021) Comparison of glycoprofiles of rituximab versions licensed for sale in India and an analytical approach for quality assessment. Journal of Proteomics 244, pages 104267.
Crossref
Josef S Smolen, Stanley B Cohen, Hans-Peter Tony, Morton Scheinberg, Alan Kivitz, Andra Balanescu, Juan Gomez-Reino, Liyi Cen, Johann Poetzl, Tamas Shisha & Dmitrij Kollins. (2021) Efficacy and safety of Sandoz biosimilar rituximab for active rheumatoid arthritis: 52-week results from the randomized controlled ASSIST-RA trial. Rheumatology 60:1, pages 256-262.
Crossref
Ali M. Alsamil, Thijs J. Giezen, Toine C. Egberts, Hubert G. Leufkens, Arnold G. Vulto, Martijn R. van der Plas & Helga Gardarsdottir. (2020) Reporting of quality attributes in scientific publications presenting biosimilarity assessments of (intended) biosimilars: a systematic literature review. European Journal of Pharmaceutical Sciences 154, pages 105501.
Crossref
Burkhard Otremba, Jens Borchardt, Andra Kuske, Maike Hollnagel-Schmitz & Florian O Losch. (2020) Real-world use and acceptance of rituximab biosimilars in non-Hodgkin lymphoma in an oncologist network in Germany. Future Oncology 16:15, pages 1001-1012.
Crossref
Zhibing Weng, Jian Jin, ChunHua Shao & Huazhong Li. (2020) Reduction of charge variants by CHO cell culture process optimization. Cytotechnology 72:2, pages 259-269.
Crossref
Wojciech Jurczak, Stanley Cohen, Timothy M Illidge, Antonio da Silva & Jutta Amersdorffer. (2019) Scientific rationale underpinning the development of biosimilar rituximab in hematological cancers and inflammatory diseases. Future Oncology 15:36, pages 4223-4234.
Crossref
V. V Pisarev, Maria M Ulyashova & Gelia N Gildeeva. (2019) Validation of Enzyme Immunoassay for Preclinical Pharmacokinetic Trials of Rituximab. The Bulletin of the Scientific Centre for Expert Evaluation of Medicinal Products 9:2, pages 131-139.
Crossref
Liang Zhang, Andreas Castan, Joanne Stevenson, Nathalie Chatzissavidou, Francisco Vilaplana & Veronique Chotteau. (2019) Combined effects of glycosylation precursors and lactate on the glycoprofile of IgG produced by CHO cells. Journal of Biotechnology 289, pages 71-79.
Crossref
Young Min Kim, Jin Se Park, Sang Kyung Kim, Kyung Min Jung, Young Sun Hwang, Mookyoung Han, Hong Jo Lee, Hee Won Seo, Jeong-Yong Suh, Beom Ku Han & Jae Yong Han. (2018) The transgenic chicken derived anti-CD20 monoclonal antibodies exhibits greater anti-cancer therapeutic potential with enhanced Fc effector functions. Biomaterials 167, pages 58-68.
Crossref
Krzysztof Giannopoulos, Tomasz Wróbel, Wojciech Jurczak, Sebastian Giebel, Iwona Hus, Wiesław Wiktor Jędrzejczak & Tadeusz Robak. (2017) Rytuksymab – pierwsze biopodobne przeciwciała monoklonalne w hematoonkologii. Acta Haematologica Polonica 48:4, pages 269-273.
Crossref
Hannah A. Blair. (2017) GP2013: A Rituximab Biosimilar. BioDrugs 31:5, pages 465-468.
Crossref
Josef S Smolen, Stanley B Cohen, Hans-Peter Tony, Morton Scheinberg, Alan Kivitz, Andra Balanescu, Juan Gomez-Reino, Liyi Cen, Peijuan Zhu & Tamas Shisha. (2017) A randomised, double-blind trial to demonstrate bioequivalence of GP2013 and reference rituximab combined with methotrexate in patients with active rheumatoid arthritis. Annals of the Rheumatic Diseases 76:9, pages 1598-1602.
Crossref
Arnold G. Vulto & Orlando A. Jaquez. (2017) The process defines the product: what really matters in biosimilar design and production?. Rheumatology 56:suppl_4, pages iv14-iv29.
Crossref
Kenta Haraya, Tatsuhiko Tachibana & Junichi Nezu. (2017) Quantitative prediction of therapeutic antibody pharmacokinetics after intravenous and subcutaneous injection in human. Drug Metabolism and Pharmacokinetics 32:4, pages 208-217.
Crossref
Wojciech Jurczak, Ilídia Moreira, Govind Babu Kanakasetty, Eduardo Munhoz, Maria Asunción Echeveste, Pratyush Giri, Nelson Castro, Juliana Pereira, Luiza Akria, Sergey Alexeev, Eugeniy Osmanov, Peijuan Zhu, Siyka Alexandrova, Angela Zubel, Olof Harlin & Jutta Amersdorffer. (2017) 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. The Lancet Haematology 4:8, pages e350-e361.
Crossref
Dae Hyun Yoo, Chang-Hee Suh, Seung Cheol Shim, Slawomir Jeka, Francisco Fidencio Cons Molina, Pawel Hrycaj, Piotr Wiland, Eun Young Lee, Francisco G. Medina-Rodriguez, Pavel Shesternya, Sebastiao Radominski, Marina Stanislav, Volodymyr Kovalenko, Dong Hyuk Sheen, Leysan Myasoutova, Mie Jin Lim, Jung-Yoon Choe, Sang Joon Lee, Sung Young Lee, Sung Hwan Kim & Won Park. (2017) Efficacy, Safety and Pharmacokinetics of Up to Two Courses of the Rituximab Biosimilar CT-P10 Versus Innovator Rituximab in Patients with Rheumatoid Arthritis: Results up to Week 72 of a Phase I Randomized Controlled Trial. BioDrugs 31:4, pages 357-367.
Crossref
Paul Baldrick. (2017) Pharmacokinetic and toxicology comparator testing of biosimilar drugs – Assessing need. Regulatory Toxicology and Pharmacology 86, pages 386-391.
Crossref
MA. Velasco-Velázquez, N. Salinas-Jazmín, E. Hisaki-Itaya, L. Cobos-Puc, W. Xolalpa, G. González, A. Tenorio-Calvo, N. Piña-Lara, LC. Juárez-Bayardo, LF. Flores-Ortiz, E. Medina-Rivero, NO. Pérez & SM. Pérez-Tapia. (2017) Extensive preclinical evaluation of an infliximab biosimilar candidate. European Journal of Pharmaceutical Sciences 102, pages 35-45.
Crossref
Ira Jacobs, Reginald Ewesuedo, Sadiq Lula & Charles Zacharchuk. (2017) Biosimilars for the Treatment of Cancer: A Systematic Review of Published Evidence. BioDrugs 31:1, pages 1-36.
Crossref
João Eurico Fonseca & João Gonçalves. 2016. Biosimilars of Monoclonal Antibodies. Biosimilars of Monoclonal Antibodies 479 503 .
Ira Jacobs, Danielle Petersel, Leah Isakov, Sadiq Lula & K. Lea Sewell. (2016) Biosimilars for the Treatment of Chronic Inflammatory Diseases: A Systematic Review of Published Evidence. BioDrugs 30:6, pages 525-570.
Crossref
Ira Jacobs, Danielle Petersel, Lesley G. Shane, Chee-Keng Ng, Carol Kirchhoff, Gregory Finch & Sadiq Lula. (2016) Monoclonal Antibody and Fusion Protein Biosimilars Across Therapeutic Areas: A Systematic Review of Published Evidence. BioDrugs 30:6, pages 489-523.
Crossref
Hope S. Rugo, Kim M. Linton, Paul Cervi, Julie A. Rosenberg & Ira Jacobs. (2016) A clinician’s guide to biosimilars in oncology. Cancer Treatment Reviews 46, pages 73-79.
Crossref
Philipp N. Spahn, Anders H. Hansen, Henning G. Hansen, Johnny Arnsdorf, Helene F. Kildegaard & Nathan E. Lewis. (2016) A Markov chain model for N-linked protein glycosylation – towards a low-parameter tool for model-driven glycoengineering. Metabolic Engineering 33, pages 52-66.
Crossref
Susan Hurst & Donghua Yin. 2010. Pharmaceutical Sciences Encyclopedia. Pharmaceutical Sciences Encyclopedia 1 16 .
Pere Gascon. (2015) The evolving role of biosimilars in haematology–oncology: a practical perspective. Therapeutic Advances in Hematology 6:6, pages 267-281.
Crossref
Lynda McEvoy. (2015) Why Biosimilars Matter: An Innovative Solution to Improve Patient Access. EMJ Hematology, pages 47-53.
Crossref
Peter J.K. van Meer, Hans C. Ebbers, Marlous Kooijman, Christine C. Gispen-de Wied, Beatriz Silva-Lima, Ellen H.M. Moors & Huub Schellekens. (2015) Contribution of animal studies to evaluate the similarity of biosimilars to reference products. Drug Discovery Today 20:4, pages 483-490.
Crossref