Literature DB >> 20062035

Clinical comparability and European biosimilar regulations.

Huub Schellekens1, Ellen Moors.   

Abstract

Mesh:

Year:  2010        PMID: 20062035     DOI: 10.1038/nbt0110-28

Source DB:  PubMed          Journal:  Nat Biotechnol        ISSN: 1087-0156            Impact factor:   54.908


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  4 in total

Review 1.  Biotechnology and drug discovery: from bench to bedside.

Authors:  Yoav Avidor; Nicola J Mabjeesh; Haim Matzkin
Journal:  South Med J       Date:  2003-12       Impact factor: 0.954

Review 2.  Follow-on biologics: challenges of the "next generation".

Authors:  Huub Schellekens
Journal:  Nephrol Dial Transplant       Date:  2005-05       Impact factor: 5.992

Review 3.  Biosimilars: how similar or dissimilar are they?

Authors:  Simon D Roger
Journal:  Nephrology (Carlton)       Date:  2006-08       Impact factor: 2.506

Review 4.  Glatiramer acetate: evidence for a dual mechanism of action.

Authors:  François Blanchette; Oliver Neuhaus
Journal:  J Neurol       Date:  2008-03       Impact factor: 4.849

  4 in total
  27 in total

Review 1.  What do prescribers think of biosimilars?

Authors:  M S Aapro
Journal:  Target Oncol       Date:  2012-01-19       Impact factor: 4.493

Review 2.  The advent of biosimilar therapies in rheumatology--"O brave new world".

Authors:  Morton A Scheinberg; Jonathan Kay
Journal:  Nat Rev Rheumatol       Date:  2012-06-05       Impact factor: 20.543

3.  The evolving role of biosimilars in haematology-oncology: a practical perspective.

Authors:  Pere Gascon
Journal:  Ther Adv Hematol       Date:  2015-12

4.  The constrained prescription, interchangeability and substitution of biosimilars.

Authors:  Paola Minghetti; Paolo Rocco; Huub Schellekens
Journal:  Nat Biotechnol       Date:  2015-07       Impact factor: 54.908

5.  The utility of hydrogen/deuterium exchange mass spectrometry in biopharmaceutical comparability studies.

Authors:  Damian Houde; Steven A Berkowitz; John R Engen
Journal:  J Pharm Sci       Date:  2010-12-29       Impact factor: 3.534

6.  Is extrapolation of the safety and efficacy data in one indication to another appropriate for biosimilars?

Authors:  Howard Lee
Journal:  AAPS J       Date:  2013-10-11       Impact factor: 4.009

7.  Next generation and biosimilar monoclonal antibodies: essential considerations towards regulatory acceptance in Europe. February 3-4, 2011, Freiburg, Germany.

Authors:  Janice M Reichert
Journal:  MAbs       Date:  2011-05-01       Impact factor: 5.857

8.  Biosimilars 2.0: guiding principles for a global "patients first" standard.

Authors:  Joseph Miletich; Geoffrey Eich; Gustavo Grampp; Barbara Mounho
Journal:  MAbs       Date:  2011-05-01       Impact factor: 5.857

9.  Patent term extensions for biologic innovators in Japan.

Authors:  John A Tessensohn; Shusaku Yamamoto
Journal:  Nat Biotechnol       Date:  2011-01       Impact factor: 54.908

10.  [Biologics. Magic bullets - magic effects - magic costs? New therapeutics and their effects].

Authors:  O Frey; T Kamradt
Journal:  Ophthalmologe       Date:  2011-01       Impact factor: 1.059

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