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Editorial

Biosimilar monoclonal antibodies: a science-based regulatory challenge

, PharmD PhD
Pages 153-156 | Published online: 04 Jan 2013

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

Read on this site (8)

Andrea Becciolini, Maria Gabriella Raimondo, Chiara Crotti, Elena Agape, Martina Biggioggero & Ennio Giulio Favalli. (2017) A review of the literature analyzing benefits and concerns of infliximab biosimilar CT-P13 for the treatment of rheumatologic diseases: focus on interchangeability. Drug Design, Development and Therapy 11, pages 1969-1978.
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Jorge Correale, Erwin Chiquete, Alexey Boyko, Roy G Beran, Jorge Barahona Strauch, Snezana Milojevic & Nadina Frider. (2016) Clinical implications for substandard, nonproprietary medicines in multiple sclerosis: focus on fingolimod. Drug Design, Development and Therapy 10, pages 2109-2117.
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Stefan Schreiber, Julian Panés, ByoungOh Kwon, SeungSuh Hong & Laurent Peyrin-Biroulet. (2015) Biosimilar infliximab for inflammatory bowel disease: from concepts to clinical practice. Case study illustrated with CT-P13. Expert Review of Gastroenterology & Hepatology 9:sup1, pages 5-15.
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Adriana Carrá, Miguel Angel Macías Islas, Adriana Tarulla, Denis Bernardi Bichuetti, Alessandro Finkelsztejn, Yara Dadalti Fragoso, Raul Árcega-Revilla, Claudia Cárcamo Rodríguez, Juan Carlos Durán, Juan García Bonitto, Rosalba León, Carlos Oehninger Gatti, Geraldine Orozco & Darwin Vizcarra Escobar. (2015) Biological and nonbiological complex drugs for multiple sclerosis in Latin America: regulations and risk management. Expert Review of Neurotherapeutics 15:6, pages 597-600.
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Catherine Rioufol & Gilles Salles. (2015) Biosimilar monoclonal antibodies in lymphoma: a critical appraisal. Expert Review of Anticancer Therapy 15:5, pages 569-578.
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Lei Zhu, Qingcheng Guo, Huaizu Guo, Tao Liu, Yingxin Zheng, Peiming Gu, Xi Chen, Hao Wang, Sheng Hou & Yajun Guo. (2014) Versatile characterization of glycosylation modification in CTLA4-Ig fusion proteins by liquid chromatography-mass spectrometry. mAbs 6:6, pages 1474-1485.
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Mark Haverick, Selina Mengisen, Mohammed Shameem & Alexandre Ambrogelly. (2014) Separation of mAbs molecular variants by analytical hydrophobic interaction chromatography HPLC: overview and applications. mAbs 6:4, pages 852-858.
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Hugh J Freeman. (2013) Developments in the treatment of moderate to severe ulcerative colitis: focus on adalimumab. Therapeutics and Clinical Risk Management 9, pages 451-456.
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Articles from other publishers (37)

Amal Ali Elkordy & Kamalinder K. Singh. 2023. Formulation of Monoclonal Antibody Therapies. Formulation of Monoclonal Antibody Therapies 39 52 .
Austin Kulasekararaj, Robert Brodsky, Alexander Kulagin & Jun Ho Jang. (2022) Biosimilars in rare diseases: a focus on paroxysmal nocturnal hemoglobinuria. Haematologica 108:5, pages 1232-1243.
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Venkata Appa Reddy Goli & Arun Butreddy. (2022) Biosimilar monoclonal antibodies: Challenges and approaches towards formulation. Chemico-Biological Interactions 366, pages 110116.
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A. Mhiri, M. Khemakhem, N. Kalboussi & B. Kacem. (2022) Connaissances et perceptions des médicaments biosimilaires par les professionnels de santé en Tunisie. Annales Pharmaceutiques Françaises 80:3, pages 327-339.
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Seyedeh Zohreh Mirjalili, Reyhaneh Sabourian, Mona Sadeghalvad & Nima Rezaei. (2021) Therapeutic applications of biosimilar monoclonal antibodies: Systematic review of the efficacy, safety, and immunogenicity in autoimmune disorders. International Immunopharmacology 101, pages 108305.
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Pekka Kurki, Sean Barry, Ingrid Bourges, Panagiota Tsantili & Elena Wolff-Holz. (2021) Safety, Immunogenicity and Interchangeability of Biosimilar Monoclonal Antibodies and Fusion Proteins: A Regulatory Perspective. Drugs 81:16, pages 1881-1896.
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Ana Martínez-Feito, Luz Yadira Bravo-Gallego, Borja Hernández-Breijo, Jesús Diez, Laura García-Ramirez, Marta Jaquotot, Chamaida Plasencia-Rodríguez, Pilar Nozal, Araceli Mezcua, María Dolores Martín- Arranz & Dora Pascual-Salcedo. (2020) Infliximab concentrations in two non-switching cohorts of patients with inflammatory bowel disease: originator vs. biosimilar. Scientific Reports 10:1.
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Marc Thill, Nicholas Thatcher, Vladimir Hanes & Gary H Lyman. (2019) Biosimilars: what the oncologist should know. Future Oncology 15:10, pages 1147-1165.
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Efraín Esteban, Rosa-Helena Bustos, Julio-César García & Edwin Jáuregui. (2019) Biosimilars: An Approach to some Current Worldwide Regulation Frameworks. Current Clinical Pharmacology 14:1, pages 16-40.
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Barbara Melosky, David A Reardon, Andrew B Nixon, Janakiraman Subramanian, Angel H Bair & Ira Jacobs. (2018) Bevacizumab biosimilars: scientific justification for extrapolation of indications. Future Oncology 14:24, pages 2507-2520.
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Ann GilsAntonio Bertolotto, Denis Mulleman, Theodora Bejan-AngoulvantPaul J. Declerck. (2017) Biopharmaceuticals: Reference Products and Biosimilars to Treat Inflammatory Diseases. Therapeutic Drug Monitoring 39:4, pages 308-315.
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Paul Declerck & Mourad Farouk Rezk. (2017) The road from development to approval: evaluating the body of evidence to confirm biosimilarity. Rheumatology 56:suppl_4, pages iv4-iv13.
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Carolina Negrei & Daniel Boda. 2017. An Interdisciplinary Approach to Psoriasis. An Interdisciplinary Approach to Psoriasis.
Francesca Pavanello, Emanuele Zucca & Michele Ghielmini. (2017) Rituximab: 13 open questions after 20years of clinical use. Cancer Treatment Reviews 53, pages 38-46.
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Shiwei Miao, Li Fan, Liang Zhao, Ding Ding, Xiaohui Liu, Haibin Wang & Wen-Song Tan. (2017) Physicochemical and Biological Characterization of the Proposed Biosimilar Tocilizumab. BioMed Research International 2017, pages 1-13.
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M.G. Cifone, B. Cinque, C. La Torre, F. Lombardi, P. Palumbo, M.E. van den Rest, C. Vuotto & G. Donelli. 2017. The Microbiota in Gastrointestinal Pathophysiology. The Microbiota in Gastrointestinal Pathophysiology 171 178 .
Valderilio Azevedo, Brian Hassett, João Eurico Fonseca, Tatsuya Atsumi, Javier Coindreau, Ira Jacobs, Ehab Mahgoub, Julie O’Brien, Ena Singh, Steven Vicik & Brian Fitzpatrick. (2016) Differentiating biosimilarity and comparability in biotherapeutics. Clinical Rheumatology 35:12, pages 2877-2886.
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Krisztina B. Gecse & Péter L. Lakatos. (2016) Biosimilar Monoclonal Antibodies for Inflammatory Bowel Disease: Current Comfort and Future Prospects. Drugs 76:15, pages 1413-1420.
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Evelien Moorkens, Clara Jonker-Exler, Isabelle Huys, Paul Declerck, Steven Simoens & Arnold G. Vulto. (2016) Overcoming Barriers to the Market Access of Biosimilars in the European Union: The Case of Biosimilar Monoclonal Antibodies. Frontiers in Pharmacology 7.
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Zichuan Zhang, Ronel Perrault, Yun Zhao & Julia Ding. (2016) SpeB proteolysis with imaged capillary isoelectric focusing for the characterization of domain-specific charge heterogeneities of reference and biosimilar Rituximab. Journal of Chromatography B 1020, pages 148-157.
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Ann Gils, Thomas Van Stappen, Erwin Dreesen, Ruth Storme, S?verine Vermeire & Paul J. Declerck. (2016) Harmonization of Infliximab and Anti-Infliximab Assays Facilitates the Comparison Between Originators and Biosimilars in Clinical Samples. Inflammatory Bowel Diseases 22:4, pages 969-975.
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Ewa Olech. (2016) Biosimilars: Rationale and current regulatory landscape. Seminars in Arthritis and Rheumatism 45:5, pages S1-S10.
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Sarfaraz Niazi. 2015. Biosimilars and Interchangeable Biologics. Biosimilars and Interchangeable Biologics 123 174 .
Sarfaraz Niazi. 2015. Biosimilars and Interchangeable Biologics. Biosimilars and Interchangeable Biologics 1 22 .
Lissy de Ridder, Matti Waterman, Dan Turner, Jiri Bronsky, Almuthe C. Hauer, Jorge A. Dias, Caterina Strisciuglio, Frank M. Ruemmele, Arie Levine & Paolo Lionetti. (2015) Use of Biosimilars in Paediatric Inflammatory Bowel Disease. Journal of Pediatric Gastroenterology & Nutrition 61:4, pages 503-508.
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Walter Reinisch & Josef Smolen. (2015) Biosimilar safety factors in clinical practice. Seminars in Arthritis and Rheumatism 44:6, pages S9-S15.
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Lynne A. Bui, Susan Hurst, Gregory L. Finch, Beverly Ingram, Ira A. Jacobs, Carol F. Kirchhoff, Chee-Keng Ng & Anne M. Ryan. (2015) Key considerations in the preclinical development of biosimilars. Drug Discovery Today 20, pages 3-15.
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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.
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Michael S. Kinch. (2015) An overview of FDA-approved biologics medicines. Drug Discovery Today 20:4, pages 393-398.
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Mark Spengler, Michael Adler & Christof M. Niemeyer. (2015) Highly sensitive ligand-binding assays in pre-clinical and clinical applications: immuno-PCR and other emerging techniques. The Analyst 140:18, pages 6175-6194.
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Sarfaraz K. Niazi. 2014. Handbook of Bioequivalence Testing. Handbook of Bioequivalence Testing 756 787 .
Geert R. D'Haens, R. Balfour Sartor, Mark S. Silverberg, Joel Petersson & Paul Rutgeerts. (2014) Future directions in inflammatory bowel disease management. Journal of Crohn's and Colitis 8:8, pages 726-734.
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Marc Alexander Radtke & Matthias Augustin. (2014) Biosimilars in psoriasis: What can we expect?. JDDG: Journal der Deutschen Dermatologischen Gesellschaft 12:4, pages 306-312.
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Edwin Choy & Ira Allen Jacobs. (2014) Biosimilar Safety Considerations in Clinical Practice. Seminars in Oncology 41, pages S3-S14.
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Jame Abraham. (2013) Developing Oncology Biosimilars: An Essential Approach for the Future. Seminars in Oncology 40, pages S5-S24.
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Jame Abraham. (2013) Introduction and Commentary: Paving the Way for Biosimilars in Oncology. Seminars in Oncology 40, pages S1-S4.
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Harald H. Sitte & Michael Freissmuth. (2013) Biosimilars versus generics: scientific basics and clinical implications. memo - Magazine of European Medical Oncology 6:3, pages 202-206.
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