Biosimilars: Key regulatory considerations and similarity assessment tools-Reference-Cited by-同舟云学术

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Biosimilars: Key regulatory considerations and similarity assessment tools

Published:2017-09-19 Issue:12 Volume:114 Page:2696-2705
ISSN:0006-3592
Container-title:Biotechnology and Bioengineering
language:en
Short-container-title:Biotechnology and Bioengineering

Author:

Kirchhoff Carol F.¹,Wang Xiao-Zhuo Michelle²,Conlon Hugh D.³,Anderson Scott⁴,Ryan Anne M.⁵,Bose Arindam⁶

Affiliation:

1. Pfizer Inc; Global Technology Services; Biotechnology and Aseptic Sciences Group; Chesterfield Missouri

2. Pfizer Inc; BioTherapeutics Pharmaceutical Sciences; Pearl River New York

3. Pfizer Inc; Analytical Research and Development; Andover Massachusetts

4. Pfizer Inc; Worldwide Regulatory; San Diego California

5. Pfizer Inc; Drug Safety Research and Development; Groton Connecticut

6. Pfizer Inc; BioTherapeutics Pharmaceutical Sciences; Groton Connecticut

Funder

Pfizer

Publisher

Wiley

Subject

Applied Microbiology and Biotechnology,Bioengineering,Biotechnology

Reference49 articles.

1. Barriers to the access and use of rituximab in patients with non-Hodgkin's lymphoma and chronic lymphocytic leukemia: A physician survey;Baer;Pharmaceuticals (Basel),2014

2. Complexities of biosimilar product;Bandyopadhyay;Journal of Bioanalysis and Biomedicine,2013

3. Anti-TNF-alpha biotherapies: Perspectives for evidence-based personalized medicine;Bendtzen;Immunotherapy,2012

4. Protein glycosylation and its impact on biotechnology;Berger;Advances in Biochemical Engineering/Biotechnology,2012

5. Taking immunogenicity assessment of therapeutic proteins to the next level;Buttel;Biologicals,2011

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1. Incidence of new fractures in older patients with osteoporosis receiving biosimilar teriparatide or reference products: A retrospective cohort study;British Journal of Clinical Pharmacology;2024-09-08

2. Biosimilar Medicines: From Development Process to Marketing Authorization by the EMA and the FDA;Applied Sciences;2024-08-26

3. Lectin-Based Fluorescent Comparison of Glycan Profile—FDA Validation to Expedite Approval of Biosimilars;International Journal of Molecular Sciences;2024-08-26

4. Real-World Use of Off-Label MVASI in the Treatment of Patients With Neovascular AMD and DME;Translational Vision Science & Technology;2024-07-23

5. Biosimilars of anti-vascular endothelial growth factor for ophthalmic diseases: A review;Survey of Ophthalmology;2024-07

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