A randomized, double blind, single dose, comparative study of the pharmacokinetics, safety and immunogenicity of MB02 (bevacizumab biosimilar) and reference bevacizumab in healthy male volunteers-Reference-Cited by-同舟云学术

A randomized, double blind, single dose, comparative study of the pharmacokinetics, safety and immunogenicity of MB02 (bevacizumab biosimilar) and reference bevacizumab in healthy male volunteers

Published:2021-09-04 Issue: Volume: Page:
ISSN:0306-5251
Container-title:British Journal of Clinical Pharmacology
language:en
Short-container-title:Br J Clin Pharmacol

Author:

Sinn Angela¹,García‐Alvarado Fernanda²^ORCID,Gonzalez Veronica²,Huerga Camino²,Bullo Felicitas²

Affiliation:

1. Early Phase Clinical Unit Berlin, Parexel International GmbH. Berlin Germany

2. Medical Department, mAbxience Research S.L. Madrid Spain

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1111/bcp.15032

Reference21 articles.

1. Vascular endothelial growth factor (VEGF) and its receptors

2. Vascular Endothelial Growth Factor (VEGF), VEGF Receptors and Their Inhibitors for Antiangiogenic Tumor Therapy

3. European Medicines Agency (EMA) Guideline on similar biological medicinal product (Rev 1).https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-similar-biological-medicinal-products-rev1_en.pdf. Accessed December 6 2020.

4. United States Federal Drug Administration (US FDA) Scientific considerations in demonstrating biosimilarity to a reference product.https://www.fda.gov/media/82647/download. Accessed December 6 2020.

5. ESMO International Consortium Study on the availability, out-of-pocket costs and accessibility of antineoplastic medicines in countries outside of Europe

Cited by 7 articles. 订阅此论文施引文献订阅此论文施引文献，注册后可以免费订阅5篇论文的施引文献，订阅后可以查看论文全部施引文献

1. Revisions to the requirement of the Japanese clinical study data for biosimilar developments in Japan;Expert Opinion on Biological Therapy;2024-07-02

2. Pooled analysis of three pharmacokinetic studies comparing biosimilar MB02 and reference bevacizumab;Pharmacology Research & Perspectives;2023-11-02

3. Translation of Monoclonal Antibodies Pharmacokinetics from Animal to Human Using Physiologically Based Modeling in Open Systems Pharmacology (OSP) Suite: A Retrospective Analysis of Bevacizumab;Pharmaceutics;2023-08-14

4. In Silico and In Vitro Evaluation of Bevacizumab Biosimilar MB02 as an Antitumor Agent in Canine Mammary Carcinoma;Animals;2023-08-03

5. A randomized, double‐blind, single‐dose study to assess bioequivalence of MB02 biosimilar after manufacturing iteration and reference bevacizumab;Pharmacology Research & Perspectives;2023-03-13