Citations (39)
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Emma Kelsall, Claire Harris, Titash Sen, Diane Hatton, Sarah Dunn & Suzanne Gibson. (2023) Interplay of heavy chain introns influences efficient transcript splicing and affects product quality of recombinant biotherapeutic antibodies from CHO cells. mAbs 15:1.
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Yaqi Lin, Heng Yang, Xiaoyan Yang, Can Guo, Shuang Yang, Guoping Yang, Qiong Wu, Chao Pan, Changan Sun, Chuan Li, Liangliang He, Jie Huang & Qi Pei. (2022) Biosimilarity of HS-20090 to Denosumab in healthy Chinese subjects: a randomized, double-blinded, pharmacokinetics/pharmacodynamics study. Expert Opinion on Investigational Drugs 31:10, pages 1125-1132.
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Claire Harris, Weichen Xu, Luigi Grassi, Chunlei Wang, Abigail Markle, Colin Hardman, Richard Stevens, Guillermo Miro-Quesada, Diane Hatton & Jihong Wang. (2019) Identification and characterization of an IgG sequence variant with an 11 kDa heavy chain C-terminal extension using a combination of mass spectrometry and high-throughput sequencing analysis. mAbs 11:8, pages 1452-1463.
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Thomas Felix, John B. Jordan, Catherine Akers, Bina Patel & Daniela Drago. (2019) Current state of biologic pharmacovigilance in the European Union: improvements are needed. Expert Opinion on Drug Safety 18:3, pages 231-240.
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Articles from other publishers (33)
Adrián Urbano, Judith Plaza, César Picado & Fernando de Mora. (2023) Combined analytical assays for the characterization of drugs binding to human IgE: Applicability to omalizumab-bearing biosimilar candidates assessment. Biomedicine & Pharmacotherapy 169, pages 115848.
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Sophia Junker, Oliver Ebert & Robert Bartsch. (2023) A Systematic Literature Review of Injection Site Pain Perception in Adult
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JongAh Joanne Lee, Nayoung Lee, Young Jun Seo & Ilkoo Kim. (2023) Consistency of Product Quality for SB5, an Adalimumab Biosimilar. BioDrugs 37:2, pages 271-277.
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Mohd. Avais & Subrata Chattopadhyay. (2022) Divergent Synthesis of Biocompatible Nearly Monodisperse Multi‐Functional Poly(ethylene glycol) Periodic Copolymers. Macromolecular Chemistry and Physics 223:17, pages 2200109.
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Ali M. Alsamil, Thijs J. Giezen, Toine C. Egberts, Erik Doevendans, Hubert G. Leufkens & Helga Gardarsdottir. (2022) Nature and timing of post-approval manufacturing changes of tumour necrosis factor α inhibitor products: A 20-year follow-up study of originators and biosimilars. European Journal of Pharmaceutical Sciences 175, pages 106227.
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S. Irem Kaya, Ahmet Cetinkaya, Mehmet G. Caglayan & Sibel A. Ozkan. (2021) Recent biopharmaceutical applications of capillary electrophoresis methods on recombinant DNA technology‐based products. ELECTROPHORESIS 43:9-10, pages 1035-1049.
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Stefka Stoyanova, Emanuil Yordanov, Emil Hristov, Iva Parvova, Hristo Tzachev & Valentina Petkova. (2021) Availability, affordability and drug utilization of biosimilar medicinal products, containing monoclonal antibodies in Bulgaria. Journal of Generic Medicines: The Business Journal for the Generic Medicines Sector 18:1, pages 42-50.
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Sara M. Shatat, Medhat A. Al-Ghobashy, Faten A. Fathalla, Samah S. Abbas & Basma M. Eltanany. (2021) Coupling of Trastuzumab chromatographic profiling with machine learning tools: A complementary approach for biosimilarity and stability assessment. Journal of Chromatography B 1184, pages 122976.
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Luisa-Fernanda Rojas-Chavarro & Fernando de Mora. (2021) Extrapolation: Experience gained from original biologics. Drug Discovery Today 26:8, pages 2003-2013.
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Christopher J. Webster, Kelly L. George & Gillian R. Woollett. (2021) Comparability of Biologics: Global Principles, Evidentiary Consistency and Unrealized Reliance. BioDrugs 35:4, pages 379-387.
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Anita Afzali, Daniel Furtner, Richard Melsheimer & Philip J. Molloy. (2021) The Automatic Substitution of Biosimilars: Definitions of Interchangeability are not Interchangeable. Advances in Therapy 38:5, pages 2077-2093.
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Meenu Wadhwa, Chris Bird, Eleanor Atkinson, Isabelle Cludts & Peter Rigsby. (2021) The First WHO International Standard for Adalimumab: Dual Role in Bioactivity and Therapeutic Drug Monitoring. Frontiers in Immunology 12.
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Sandra Prior, Clive Metcalfe, Simon E. Hufton, Meenu Wadhwa, Christian K. Schneider & Chris Burns. (2021) Maintaining ‘standards’ for biosimilar monoclonal antibodies. Nature Biotechnology 39:3, pages 276-280.
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Yuning Zhang, Pablo Mesa-Antunez, Lisa Fortuin, Oliver C. J. Andrén & Michael Malkoch. (2020) Degradable High Molecular Weight Monodisperse Dendritic Poly(ethylene glycols). Biomacromolecules 21:10, pages 4294-4301.
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Hillel P. Cohen & Dorothy McCabe. (2020) The Importance of Countering Biosimilar Disparagement and Misinformation. BioDrugs 34:4, pages 407-414.
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Hans C. Ebbers, Bjørn Fehrmann, Mette Ottosen, Niels Hvorslev, Pia Høier, Jae-Woong Hwang, Jinhan Chung, Hyoung Taek Lim, Shinjung Lee, Juyoung Hong & Mourad Farouk Rezk. (2020) Batch-to-Batch Consistency of SB4 and SB2, Etanercept and Infliximab Biosimilars. BioDrugs 34:2, pages 225-233.
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Christopher J. Webster, Anny C. Wong & Gillian R. Woollett. (2019) An Efficient Development Paradigm for Biosimilars. BioDrugs 33:6, pages 603-611.
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Fernando Mora, Alejandro Balsa, María Cornide‐Santos, Jose‐Manuel Carrascosa, Sara Marsal, Javier P. Gisbert, Miguel‐Angel Abad, Rafael F. Duarte, Michael Wiechmann & Rafael Martínez. (2019) Biosimilar and interchangeable: Inseparable scientific concepts?. British Journal of Clinical Pharmacology 85:11, pages 2460-2463.
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Chien-Lung Tu, Yi-Lin Wang, Teh-Min Hu & Li-Feng Hsu. (2019) Analysis of Pharmacokinetic and Pharmacodynamic Parameters in EU- Versus US-Licensed Reference Biological Products: Are In Vivo Bridging Studies Justified for Biosimilar Development?. BioDrugs 33:4, pages 437-446.
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