Literature DB >> 29443651

American Society of Clinical Oncology Statement: Biosimilars in Oncology.

Gary H Lyman1, Edward Balaban1, Michael Diaz1, Andrea Ferris1, Anne Tsao1, Emile Voest1, Robin Zon1, Michael Francisco1, Sybil Green1, Shimere Sherwood1, R Donald Harvey1, Richard L Schilsky1.   

Abstract

As many biosimilars come to market in the next several years, their use in oncology will play an important role in the future care of patients with cancer. ASCO is committed to providing education and guidance to the oncology community on the use of biosimilars in the cancer setting; therefore, ASCO has developed this statement to offer guidance in the following areas: (1) naming, labeling, and other regulatory considerations, (2) safety and efficacy of biosimilars, (3) interchangeability, switching, and substitution, (4) value of biosimilars, and (5) prescriber and patient education.

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Year:  2018        PMID: 29443651     DOI: 10.1200/JCO.2017.77.4893

Source DB:  PubMed          Journal:  J Clin Oncol        ISSN: 0732-183X            Impact factor:   44.544


  20 in total

1.  Regulatory and Clinical Experiences with Biosimilar Filgrastim in the U.S., the European Union, Japan, and Canada.

Authors:  Brian Chen; Sumimasa Nagai; James O Armitage; Bartlett Witherspoon; Chadi Nabhan; Ashley C Godwin; Y Tony Yang; Anuhya Kommalapati; Sri Harsha Tella; Carlo DeAngelis; Dennis W Raisch; Oliver Sartor; William J Hrushesky; Paul S Ray; Paul R Yarnold; Bryan L Love; LeAnn B Norris; Kevin Knopf; Laura Bobolts; Joshua Riente; Stefano Luminari; Robert C Kane; Shamia Hoque; Charles L Bennett
Journal:  Oncologist       Date:  2019-03-06

Review 2.  Are Biosimilars the Future of Oncology and Haematology?

Authors:  Pier Luigi Zinzani; Martin Dreyling; William Gradishar; Marc Andre; Francisco J Esteva; Suliman Boulos; Eva González Barca; Giuseppe Curigliano
Journal:  Drugs       Date:  2019-10       Impact factor: 9.546

3.  Retrospective Indication-Matched Cohort Study of Reference Product and Biosimilar: Bevacizumab Versus Bevacizumab-Awwb.

Authors:  Jennifer Philippon Booth; Jeffrey Pilz
Journal:  Hosp Pharm       Date:  2021-09-16

Review 4.  A Developer's Perspective on Clinical Evidence and Benefits for Rituximab Biosimilar Uptake, with a Focus on CT-P10.

Authors:  Dasom Choi; Soohyun Lee; Seungmin Kim; Sangwook Yoon
Journal:  Clin Drug Investig       Date:  2022-03-24       Impact factor: 2.859

5.  A comparison of eflapegrastim to pegfilgrastim in the management of chemotherapy-induced neutropenia in patients with early-stage breast cancer undergoing cytotoxic chemotherapy (RECOVER): A Phase 3 study.

Authors:  Patrick Wayne Cobb; Yong Wha Moon; Klára Mezei; István Láng; Gajanan Bhat; Shanta Chawla; Steven J Hasal; Lee S Schwartzberg
Journal:  Cancer Med       Date:  2020-07-20       Impact factor: 4.452

Review 6.  Barriers towards effective pharmacovigilance systems of biosimilars in rheumatology: A Latin American survey.

Authors:  Gilberto Castañeda-Hernández; Hugo Sandoval; Javier Coindreau; Luis Felipe Rodriguez-Davison; Carlos Pineda
Journal:  Pharmacoepidemiol Drug Saf       Date:  2019-05-30       Impact factor: 2.890

7.  PF-06439535 (a Bevacizumab Biosimilar) Compared with Reference Bevacizumab (Avastin®), Both Plus Paclitaxel and Carboplatin, as First-Line Treatment for Advanced Non-Squamous Non-Small-Cell Lung Cancer: A Randomized, Double-Blind Study.

Authors:  Niels Reinmuth; Maciej Bryl; Igor Bondarenko; Kostas Syrigos; Vladimir Vladimirov; Manuela Zereu; Angel H Bair; Fiona Hilton; Katherine Liau; Kazuo Kasahara
Journal:  BioDrugs       Date:  2019-10       Impact factor: 5.807

8.  The Importance of Countering Biosimilar Disparagement and Misinformation.

Authors:  Hillel P Cohen; Dorothy McCabe
Journal:  BioDrugs       Date:  2020-08       Impact factor: 5.807

9.  Academic oncology clinicians' understanding of biosimilars and information needed before prescribing.

Authors:  John W Cook; Megan K McGrath; Margie D Dixon; Jeffrey M Switchenko; R Donald Harvey; Rebecca D Pentz
Journal:  Ther Adv Med Oncol       Date:  2019-01-06       Impact factor: 8.168

10.  Assessing Clinical Equivalence in Oncology Biosimilar Trials With Time-to-Event Outcomes.

Authors:  Hajime Uno; Deborah Schrag; Dae Hyun Kim; Dejun Tang; Lu Tian; Hope S Rugo; Lee-Jen Wei
Journal:  JNCI Cancer Spectr       Date:  2019-08-01
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