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Biosimilars: the science of extrapolation

Blood, 2014-11, Vol.124 (22), p.3191-3196

2014

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Biosimilars: what clinicians should know

Blood, 2012-12, Vol.120 (26), p.5111-5117

2012

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The process defines the product: what really matters in biosimilar design and production?

Rheumatology (Oxford, England), 2017-08, Vol.56 (suppl_4), p.iv14-iv29

2017

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Shift From Adalimumab Originator to Biosimilars in Denmark

JAMA internal medicine, 2020-06, Vol.180 (6), p.902

2020

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Awareness, Knowledge, and Perceptions of Biosimilars Among Specialty Physicians

Advances in therapy, 2017-01, Vol.33 (12), p.2160-2172

2017

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

mAbs, 2017-05, Vol.9 (4), p.704-714

2017

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Canadian Perspectives on Using Pharmacodynamic Markers for Biosimilar Development and Authorization

Clinical pharmacology and therapeutics, 2023-01, Vol.113 (1), p.27-29

Wang, Jian

2023

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A Clinical Review of Biosimilars Approved in Oncology

The Annals of pharmacotherapy, 2021-03, Vol.55 (3), p.362

2021

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Biosimilars for Retinal Diseases: An Update

American journal of ophthalmology, 2021-04, Vol.224, p.36-42

2021

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Randomized multicenter noninferiority phase III clinical trial of the first biosimilar of eculizumab

Annals of hematology, 2021-11, Vol.100 (11), p.2689-2698

2021

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Considerations for Use of Pharmacodynamic Biomarkers to Support Biosimilar Development – (II) A Randomized Trial with IL‐5 Antagonists

Clinical pharmacology and therapeutics, 2023-01, Vol.113 (1), p.80-89

2023

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QbD-guided pharmaceutical development of Pembrolizumab biosimilar candidate PSG-024 propelled to industry meeting primary requirements of comparability to Keytruda

European journal of pharmaceutical sciences, 2022-06, Vol.173, p.106171-106171, Article 106171

2022

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Bioequivalence of Biosimilar Tumor Necrosis Factor-α Inhibitors Compared With Their Reference Biologics: A Systematic Review

Annals of internal medicine, 2016-10, Vol.165 (8), p.565

2016

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Physicochemical and biological characterization of SB2, a biosimilar of Remicade® (infliximab)

mAbs, 2017-02, Vol.9 (2), p.364-383

2017

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Barriers to Oncology Biosimilars Uptake in the United States

The oncologist (Dayton, Ohio), 2018-11, Vol.23 (11), p.1261-1265

2018

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Physicochemical characterization of Remsima

mAbs, 2014-09, Vol.6 (5), p.1163-1177

2014

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

mAbs, 2016-10, Vol.8 (7), p.1210-1223

2016

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Analytical Similarity of a Proposed Biosimilar BVZ-BC to Bevacizumab

Analytical chemistry (Washington), 2020-02, Vol.92 (4), p.3161-3170

2020

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Key considerations in the preclinical development of biosimilars

Drug discovery today, 2015-05, Vol.20, p.3-15

2015

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Emerging biologics in inflammatory bowel disease

Journal of Gastroenterology, 2017-02, Vol.52 (2), p.141-150

2017

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Developing the Totality of Evidence for Biosimilars: Regulatory Considerations and Building Confidence for the Healthcare Community

BioDrugs : clinical immunotherapeutics, biopharmaceuticals, and gene therapy, 2017-06, Vol.31 (3), p.175-187

2017

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Building better biobetters: From fundamentals to industrial application

Drug discovery today, 2022-01, Vol.27 (1), p.65-81

2022

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The Global Need for a Trastuzumab Biosimilar for Patients With HER2-Positive Breast Cancer

Clinical breast cancer, 2018-04, Vol.18 (2), p.95-113

2018

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A Randomized, Double-Blind, Efficacy and Safety Study of PF-05280586 (a Rituximab Biosimilar) Compared with Rituximab Reference Product (MabThera®) in Subjects with Previously Untreated CD20-Positive, Low-Tumor-Burden Follicular Lymphoma (LTB-FL)

BioDrugs : clinical immunotherapeutics, biopharmaceuticals, and gene therapy, 2020-04, Vol.34 (2), p.171-181

2020

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Biosimilars: the science of extrapolation

Biosimilars: what clinicians should know

The process defines the product: what really matters in biosimilar design and production?

Shift From Adalimumab Originator to Biosimilars in Denmark

Awareness, Knowledge, and Perceptions of Biosimilars Among Specialty Physicians

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

Canadian Perspectives on Using Pharmacodynamic Markers for Biosimilar Development and Authorization

A Clinical Review of Biosimilars Approved in Oncology

Biosimilars for Retinal Diseases: An Update

Randomized multicenter noninferiority phase III clinical trial of the first biosimilar of eculizumab

Considerations for Use of Pharmacodynamic Biomarkers to Support Biosimilar Development – (II) A Randomized Trial with IL‐5 Antagonists

QbD-guided pharmaceutical development of Pembrolizumab biosimilar candidate PSG-024 propelled to industry meeting primary requirements of comparability to Keytruda

Bioequivalence of Biosimilar Tumor Necrosis Factor-α Inhibitors Compared With Their Reference Biologics: A Systematic Review

Physicochemical and biological characterization of SB2, a biosimilar of Remicade® (infliximab)

Barriers to Oncology Biosimilars Uptake in the United States

Physicochemical characterization of Remsima

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

Analytical Similarity of a Proposed Biosimilar BVZ-BC to Bevacizumab

Key considerations in the preclinical development of biosimilars

Emerging biologics in inflammatory bowel disease

Developing the Totality of Evidence for Biosimilars: Regulatory Considerations and Building Confidence for the Healthcare Community

Building better biobetters: From fundamentals to industrial application

The Global Need for a Trastuzumab Biosimilar for Patients With HER2-Positive Breast Cancer

Efficacy, pharmacokinetics, and safety of the biosimilar CT-P10 compared with rituximab in patients with previously untreated advanced-stage follicular lymphoma: a randomised, double-blind, parallel-group, non-inferiority phase 3 trial

A Randomized, Double-Blind, Efficacy and Safety Study of PF-05280586 (a Rituximab Biosimilar) Compared with Rituximab Reference Product (MabThera®) in Subjects with Previously Untreated CD20-Positive, Low-Tumor-Burden Follicular Lymphoma (LTB-FL)

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