A pharmacokinetics and pharmacodynamics equivalence trial of the proposed pegfilgrastim biosimilar, MYL-1401H, versus reference pegfilgrastim-Reference-Cited by-同舟云学术

A pharmacokinetics and pharmacodynamics equivalence trial of the proposed pegfilgrastim biosimilar, MYL-1401H, versus reference pegfilgrastim

Published:2018-04-18 Issue:6 Volume:144 Page:1087-1095
ISSN:0171-5216
Container-title:Journal of Cancer Research and Clinical Oncology
language:en
Short-container-title:J Cancer Res Clin Oncol

Author:

Waller Cornelius F.^ORCID,Tiessen Renger G.,Lawrence Tracey E.,Shaw Andrew,Liu Mark Shiyao,Sharma Rajiv,Baczkowski Mark,Kothekar Mudgal A.,Micales Catherine E.,Barve Abhijit,Ranganna Gopinath M.,Pennella Eduardo J.

Funder

Mylan Inc.

Biocon Ltd

Publisher

Springer Science and Business Media LLC

Subject

Cancer Research,Oncology,General Medicine

Link

http://link.springer.com/article/10.1007/s00432-018-2643-3/fulltext.html

Reference22 articles.

1. Aapro MS, Bohlius J, Cameron DA et al (2011) 2010 update of EORTC guidelines for the use of granulocyte-colony stimulating factor to reduce the incidence of chemotherapy-induced febrile neutropenia in adult patients with lymphoproliferative disorders and solid tumours. Eur J Cancer 47:8–32

2. Blackstone EA, Joseph PF (2013) The economics of biosimilars. Am Health Drug Benefits 6:469–478

3. Blackwell K, Semiglazov V, Krasnozhon D et al (2015) Comparison of EP2006, a filgrastim biosimilar, to the reference: a phase III, randomized, double-blind clinical study in the prevention of severe neutropenia in patients with breast cancer receiving myelosuppressive chemotherapy. Ann Oncol 26:1948–1953

4. Buchner A, Lammerich A, Abdolzade-Bavil A, Müller U, Bias P (2014) Lipegfilgrastim: pharmacodynamics and pharmacokinetics for body-weight-adjusted and 6 mg fixed doses in two randomized studies in healthy volunteers. Curr Med Res Opin 30:2523–2533

5. Crobu D, Spinetti G, Schrepfer R et al (2014) Preclinical and clinical phase I studies of a new recombinant filgrastim (BK0023) in comparison with Neupogen®. BMC Pharmacol Toxicol 15:7

Cited by 25 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. Achieving white blood cell equity: are the safety profiles of biosimilar and reference pegfilgrastims comparable?;Future Oncology;2023-08-23

2. Comparative effectiveness of pegfilgrastim biosimilars vs originator for prevention of febrile neutropenia: A retrospective cohort study;Journal of Managed Care & Specialty Pharmacy;2023-02

3. Cost-effectiveness analysis of pegfilgrastim in patients with non-small cell lung cancer receiving ramucirumab plus docetaxel in Japan;Supportive Care in Cancer;2022-05-07

5. Pharmacokinetic and pharmacodynamic considerations in the development of biotechnology products and large molecules;Atkinson's Principles of Clinical Pharmacology;2022