Literature DB >> 23714845

Biosimilars in 3D: definition, development and differentiation.

Ivo Abraham1, Diana Sun, Alaa Bagalagel, Ahmed Altyar, Abdulaziz Mohammed, Soba Tharmarajah, Karen MacDonald.   

Abstract

Keywords:  biopharmaceuticals; biosimilars; follow-on biologics; interchangeable; regulatory; substitution

Mesh：

Substances：

Year:  2013        PMID： 23714845      PMCID： PMC3728190          DOI： 10.4161/bioe.25067

Source DB:  PubMed          Journal:  Bioengineered        ISSN： 2165-5979            Impact factor:   3.269


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  15 in total

Review 1.  Bioequivalence and the immunogenicity of biopharmaceuticals.

Authors:  Huub Schellekens
Journal:  Nat Rev Drug Discov       Date:  2002-06       Impact factor: 84.694

Review 2.  Immunogenicity of rDNA-derived pharmaceuticals.

Authors:  Jean-Charles Ryff; Huub Schellekens
Journal:  Trends Pharmacol Sci       Date:  2002-06       Impact factor: 14.819

Review 3.  Biosimilar, biobetter, and next generation antibody characterization by mass spectrometry.

Authors:  Alain Beck; Sarah Sanglier-Cianférani; Alain Van Dorsselaer
Journal:  Anal Chem       Date:  2012-05-14       Impact factor: 6.986

4.  How similar do 'biosimilars' need to be?

Authors:  Huub Schellekens
Journal:  Nat Biotechnol       Date:  2004-11       Impact factor: 54.908

5.  Update on the MONITOR-GCSF study of biosimilar filgrastim to reduce the incidence of chemotherapy-induced febrile neutropenia in cancer patients: Protocol amendments.

Authors:  Pere Gascón; Matti Aapro; Heinz Ludwig; Nadia Rosencher; M Boccadoro; Matthew Turner; Karen MacDonald; Michael Muenzberg; Ivo Abraham
Journal:  Crit Rev Oncol Hematol       Date:  2011-03       Impact factor: 6.312

6.  Key concepts and critical issues on epoetin and filgrastim biosimilars. A position paper from the Italian Society of Hematology, Italian Society of Experimental Hematology, and Italian Group for Bone Marrow Transplantation.

Authors:  Giovanni Barosi; Alberto Bosi; Maria P Abbracchio; Romano Danesi; Armando Genazzani; Paolo Corradini; Fabrizio Pane; Sante Tura
Journal:  Haematologica       Date:  2011-07       Impact factor: 9.941

Review 7.  Clinical safety of biosimilar recombinant human granulocyte colony-stimulating factors.

Authors:  Ivo Abraham; Soba Tharmarajah; Karen MacDonald
Journal:  Expert Opin Drug Saf       Date:  2013-02-18       Impact factor: 4.250

8.  Background and methodology of MONITOR-GCSF, a pharmaco-epidemiological study of the multi-level determinants, predictors, and clinical outcomes of febrile neutropenia prophylaxis with biosimilar granulocyte-colony stimulating factor filgrastim.

Authors:  Pere Gascón; Matti Aapro; Heinz Ludwig; Nadia Rosencher; Matthew Turner; MinKyoung Song; Karen MacDonald; Christopher Lee; Michael Muenzberg; Ivo Abraham
Journal:  Crit Rev Oncol Hematol       Date:  2010-03-01       Impact factor: 6.312

Review 9.  Clinical safety of biosimilar recombinant human erythropoietins.

Authors:  Ivo Abraham; Karen MacDonald
Journal:  Expert Opin Drug Saf       Date:  2012-08-13       Impact factor: 4.250

10.  Biosimilar therapeutics-what do we need to consider?

Authors:  Huub Schellekens
Journal:  NDT Plus       Date:  2009-01
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  5 in total

Review 1.  A Framework for Integrating Biosimilars Into the Didactic Core Requirements of a Doctor of Pharmacy Curriculum.

Authors:  Edward Li; Jennifer Liu; Monica Ramchandani
Journal:  Am J Pharm Educ       Date:  2017-04       Impact factor: 2.047

2.  Budget Impact Analysis of Switching to Rituximab's Biosimilar in Rheumatology and Cancer in 13 Countries Within the Middle East and North Africa.

Authors:  Ammar Almaaytah
Journal:  Clinicoecon Outcomes Res       Date:  2020-09-15

Review 3.  State-of-the-art biosimilar erythropoietins in the management of renal anemia: lessons learned from Europe and implications for US nephrologists.

Authors:  Adrian Covic; Ivo Abraham
Journal:  Int Urol Nephrol       Date:  2015-07-30       Impact factor: 2.370

Review 4.  Epoetin zeta in the management of anemia associated with chronic kidney disease, differential pharmacology and clinical utility.

Authors:  Mary Lynn Davis-Ajami; Jun Wu; Katherine Downton; Emilie Ludeman; Virginia Noxon
Journal:  Biologics       Date:  2014-04-16

Review 5.  Developing the Totality of Evidence for Biosimilars: Regulatory Considerations and Building Confidence for the Healthcare Community.

Authors:  Richard Markus; Jennifer Liu; Monica Ramchandani; Diana Landa; Teresa Born; Primal Kaur
Journal:  BioDrugs       Date:  2017-06       Impact factor: 5.807
  5 in total

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