Literature DB >> 27668063

Zarxio (Filgrastim-sndz): First Biosimilar Approved in the United States.

Lisa A Raedler.   

Abstract

Year:  2016        PMID： 27668063      PMCID： PMC5013845     

Source DB:  PubMed          Journal:  Am Health Drug Benefits        ISSN： 1942-2962


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  3 in total

1.  Biosimilars: part 1: proposed regulatory criteria for FDA approval.

Authors:  C Lee Ventola
Journal:  P T       Date:  2013-05

Review 2.  The colony-stimulating factors and cancer.

Authors:  Donald Metcalf
Journal:  Nat Rev Cancer       Date:  2010-06       Impact factor: 60.716

3.  A Comparison of Proposed Biosimilar LA-EP2006 and Reference Pegfilgrastim for the Prevention of Neutropenia in Patients With Early-Stage Breast Cancer Receiving Myelosuppressive Adjuvant or Neoadjuvant Chemotherapy: Pegfilgrastim Randomized Oncology (Supportive Care) Trial to Evaluate Comparative Treatment (PROTECT-2), a Phase III, Randomized, Double-Blind Trial.

Authors:  Kimberly Blackwell; Roman Donskih; C Michael Jones; Allen Nixon; Maria J Vidal; Roumen Nakov; Pritibha Singh; Gregor Schaffar; Pere Gascón; Nadia Harbeck
Journal:  Oncologist       Date:  2016-04-18
  3 in total
  7 in total

1.  A SPECIAL MEETING REVIEW EDITION: Highlights in Biosimilars From the World Congress of Gastroenterology at ACG 2017: Introduction: A Review of Selected Presentations From the World Congress of Gastroenterology at ACG 2017 • October 13-18, 2017 • Orlando, FloridaSpecial Reporting on:• Biosimilars: What Are They and How Will They Change the Way We Practice?• Infliximab Assay Used in Clinical Practice Validated for Measuring SB2 Infliximab Biosimilar's Serum Drug and Anti-Drug Antibody Levels• Efficacy of Infliximab Biosimilar for Induction and Maintenance Therapy in Inflammatory Bowel Disease After Switch From Drug Originator: A Meta-Analysis• Long-Term Efficacy, Safety, and Immunogenicity Data From a Phase III Confirmatory Study Comparing GP2017, a Proposed Biosimilar, With Reference Adalimumab• Patient Perceptions Regarding the Use of Biosimilars in Inflammatory Bowel Disease• FDA Public Forum on BiosimilarsWith an Introduction and Expert Commentary by:Gary R. Lichtenstein, MDProfessor of MedicineDirector, Center for Inflammatory Bowel DiseaseUniversity of Pennsylvania Health SystemHospital of the University of PennsylvaniaPhiladelphia, Pennsylvania.

Authors: 
Journal:  Gastroenterol Hepatol (N Y)       Date:  2017-12

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

Authors:  Cornelius F Waller; Renger G Tiessen; Tracey E Lawrence; Andrew Shaw; Mark Shiyao Liu; Rajiv Sharma; Mark Baczkowski; Mudgal A Kothekar; Catherine E Micales; Abhijit Barve; Gopinath M Ranganna; Eduardo J Pennella
Journal:  J Cancer Res Clin Oncol       Date:  2018-04-18       Impact factor: 4.553

Review 3.  Cancer biologics made in plants.

Authors:  Matthew Dent; Nobuyuki Matoba
Journal:  Curr Opin Biotechnol       Date:  2019-11-27       Impact factor: 9.740

Review 4.  The role of biosimilars in value-based oncology care.

Authors:  Kashyap B Patel; Luiz H Arantes; Wing Yu Tang; Selwyn Fung
Journal:  Cancer Manag Res       Date:  2018-10-17       Impact factor: 3.989

5.  Incidence of febrile neutropenia during chemotherapy among patients with nonmyeloid cancer receiving filgrastim vs a filgrastim biosimilar.

Authors:  Lee S Schwartzberg; Lincy S Lal; Sanjeev Balu; Kim Campbell; Lee Brekke; Caitlin Elliott; Stephanie Korrer
Journal:  Clinicoecon Outcomes Res       Date:  2018-09-03

Review 6.  The Breakthrough of Biosimilars: A Twist in the Narrative of Biological Therapy.

Authors:  Eva Rahman Kabir; Shannon Sherwin Moreino; Mohammad Kawsar Sharif Siam
Journal:  Biomolecules       Date:  2019-08-24

7.  Does use of biosimilar G-CSF change plerixafor utilization during stem cell mobilization for autologous stem cell transplant?

Authors:  Nadine Abdallah; Seongho Kim; Lois Ayash; Scott Klimecki; Marie Ventimiglia; Asif Alavi; Voravit Ratanatharathorn; Joseph Uberti; Abhinav Deol
Journal:  Bone Marrow Transplant       Date:  2019-11-18       Impact factor: 5.483
  7 in total

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