Keyword

biosimilar development

Description: Biosimilar development is the process of designing, testing, and evaluating biological medicines to establish similarity to an approved reference product.

Primary topic: Biosimilars and Bioanalytical Methods (83%)

OpenAlex ID: keywords/biosimilar-development

2012 · Martina Weise, Marie-Christine Bielsky, et al. · Blood · 362

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Worldwide experience with biosimilar development

2011 · Mark McCamish, Gillian Woollett · mAbs · 199

Developing the Nation's Biosimilars Program

2011 · Steven Kozlowski, Janet Woodcock, et al. · New England Journal of Medicine · 194

The Language of Biosimilars: Clarification, Definitions, and Regulatory Aspects

2017 · Paul Declerck, Romano Danesi, et al. · Drugs · 168

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Drifts in ADCC-related quality attributes of Herceptin®: Impact on development of a trastuzumab biosimilar

2017 · Seokkyun Kim, Jinsu Song, et al. · mAbs · 140

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In-depth structural characterization of Kadcyla® (ado-trastuzumab emtansine) and its biosimilar candidate

2016 · Liuxi Chen, Lan Wang, et al. · mAbs · 128

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2022 · Neh Nupur, Srishti Joshi, et al. · Frontiers in Bioengineering and Biotechnology · 100

An Overview of Biosimilars—Development, Quality, Regulatory Issues, and Management in Healthcare

2024 · Filipa Mascarenhas-Melo, Mariana Diaz, et al. · Pharmaceuticals · 74

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2015 · Lilian Rumi Tsuruta, Mariana Lopes dos Santos, et al. · Biotechnology Progress · 74

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Monoclonal antibodies biosimilarity assessment using transient isotachophoresis capillary zone electrophoresis-tandem mass spectrometry

2014 · Rabah Gahoual, Michaël Biacchi, et al. · mAbs · 69

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Applications of imaged capillary isoelectric focussing technique in development of biopharmaceutical glycoprotein‐based products

2012 · Carrie L. Anderson, Yang Wang*, et al. · Electrophoresis · 55

Expert perspectives on biosimilar monoclonal antibodies in breast cancer

2014 · J. Cortés, G. Curigliano, et al. · Breast Cancer Research and Treatment · 50

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Knowledge and use of biosimilars in oncology: a survey by the European Society for Medical Oncology

2019 · Rosa Giuliani, Josep Tabernero, et al. · ESMO Open · 49

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Automated Antibody De Novo Sequencing and Its Utility in Biopharmaceutical Discovery

2017 · K. Ilker Sen, Wilfred H Tang, et al. · Journal of the American Society for Mass Spectrometry · 42

Biosimilars Have Arrived: Rituximab

2018 · Maria Greenwald, John Tesser, et al. · Arthritis · 40

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Neoadjuvant Breast Cancer Treatment as a Sensitive Setting for Trastuzumab Biosimilar Development and Extrapolation

2014 · Christian Jackisch, Frank A Scappaticci, et al. · Future Oncology · 39

2016 · Niti Goel, Kamali Chance · Lara D. Veeken · 35

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Future Evolution of Biosimilar Development by Application of Current Science and Available Evidence: The Developer’s Perspective

2023 · Hillel P. Cohen, Matthew Turner, et al. · BioDrugs · 32

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The Coming of Age of Biosimilars: A Personal Perspective

2022 · Sarfaraz K. Niazi · Biologics · 30

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A rapid method for relative quantification of N -glycans from a therapeutic monoclonal antibody during trastuzumab biosimilar development

2020 · Zaneer Segu, Todd Stone, et al. · mAbs · 29

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Demystifying Biosimilars: Development, Regulation and Clinical Use

2018 · Hope S Rugo, Robert M Rifkin, et al. · Future Oncology · 29

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The totality-of-the-evidence approach to the development and assessment of GP2015, a proposed etanercept biosimilar

2017 · Vibeke Strand, Giampiero Girolomoni, et al. · Current Medical Research and Opinion · 29

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2025 · Ankit Monga, Gagan, et al. · AAPS PharmSciTech · 26

2016 · João Gonçalves, Filipe Araújo, et al. · PubMed · 26

Global regulatory landscape of biosimilars: emerging and established market perspectives

2015 · Hemant Malhotra, Anita Krishnan, et al. · Biosimilars · 26

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Works count: 364

Citation count: 2,900