Literature DB >> 22606078

Innovation and Competition: Will Biosimilars Succeed?: The creation of an FDA approval pathway for biosimilars is complex and fraught with hazard. Yes, innovation and market competition are at stake. But so are efficacy and patient safety.

Erwin A Blackstone, Joseph P Fuhr.   

Abstract

Biosimilars are here, but there's no clear pathway yet for their approval. Difficult realities about their effect on drug prices, innovation, and competition need to be faced.

Entities:  

Year:  2012        PMID： 22606078      PMCID： PMC3351893     

Source DB:  PubMed          Journal:  Biotechnol Healthc        ISSN： 1554-169X


  3 in total

1.  Satisfaction GuaranteedOr Your Money Back.

Authors:  Bob Carlson
Journal:  Biotechnol Healthc       Date:  2009-10

2.  Biosimilars and innovation: an analysis of the possibility of increased competition in biopharmaceuticals.

Authors:  Erwin A Blackstone; Joseph P Fuhr
Journal:  Future Med Chem       Date:  2010-11       Impact factor: 3.808

3.  Developing the nation's biosimilars program.

Authors:  Steven Kozlowski; Janet Woodcock; Karen Midthun; Rachel Behrman Sherman
Journal:  N Engl J Med       Date:  2011-08-04       Impact factor: 91.245
  3 in total
  21 in total

Review 1.  Biosimilarity Versus Manufacturing Change: Two Distinct Concepts.

Authors:  Paul Declerck; Mourad Farouk-Rezk; Pauline M Rudd
Journal:  Pharm Res       Date:  2015-09-17       Impact factor: 4.200

2.  Evaluation of Biosimilars for Formulary Inclusion: Factors for Consideration by P&T Committees.

Authors:  C Lee Ventola
Journal:  P T       Date:  2015-10

3.  Biosimilars: part 2: potential concerns and challenges for p&t committees.

Authors:  C Lee Ventola
Journal:  P T       Date:  2013-06

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

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

5.  Adalimumab in Psoriasis: How Much Is Enough?

Authors:  Allison C Billi; Johann E Gudjonsson
Journal:  J Invest Dermatol       Date:  2019-01       Impact factor: 8.551

6.  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

7.  The approval process for biosimilar erythropoiesis-stimulating agents.

Authors:  Jay B Wish
Journal:  Clin J Am Soc Nephrol       Date:  2014-06-26       Impact factor: 8.237

8.  Comparability of biosimilar filgrastim with originator filgrastim: protein characterization, pharmacodynamics, and pharmacokinetics.

Authors:  Fritz Sörgel; Arnd Schwebig; Johann Holzmann; Stefan Prasch; Pritibha Singh; Martina Kinzig
Journal:  BioDrugs       Date:  2015-04       Impact factor: 5.807

9.  Biosimilars: new promise for reducing healthcare costs.

Authors:  Julia Munsch
Journal:  J Biomed Res       Date:  2014-03-20

10.  The cost of biologics for psoriasis is increasing.

Authors:  Judy Cheng; Steven R Feldman
Journal:  Drugs Context       Date:  2014-12-17
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