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There are 5463 results for: content related to: Comments on the FDA draft guidance on biosimilar products

  1. You have full text access to this OnlineOpen article
    Biosimilars advancements: Moving on to the future

    Biotechnology Progress

    Volume 31, Issue 5, September/October 2015, Pages: 1139–1149, Lilian Rumi Tsuruta, Mariana Lopes dos Santos and Ana Maria Moro

    Article first published online : 16 MAR 2015, DOI: 10.1002/btpr.2066

  2. Biosimilar Drugs

    Pharmaceutical Biotechnology: Drug Discovery and Clinical Applications, Second Edition

    Oliver Kayser, Heribert Warzecha, Pages: 285–335, 2012

    Published Online : 17 APR 2012, DOI: 10.1002/9783527632909.ch13

  3. You have full text access to this OnlineOpen article
    Biosimilar granulocyte–colony-stimulating factor for healthy donor stem cell mobilization: need we be afraid?

    Transfusion

    Volume 55, Issue 2, February 2015, Pages: 430–439, Halvard Bonig, Petra S. Becker, Arnd Schwebig and Matthew Turner

    Article first published online : 26 JUN 2014, DOI: 10.1111/trf.12770

  4. Regulatory Strategies and Lessons in the Development of Biosimilars

    Standard Article

    Pharmaceutical Sciences Encyclopedia

    Umang S. Shah

    Published Online : 25 NOV 2013, DOI: 10.1002/9780470571224.pse511

  5. The State of the Art in the Development of Biosimilars

    Clinical Pharmacology & Therapeutics

    Volume 91, Issue 3, March 2012, Pages: 405–417, Mark McCamish and Gillian Woollett

    Article first published online : 8 FEB 2012, DOI: 10.1038/clpt.2011.343

  6. Biosimilar Development: Nonclinical and Clinical Strategies and Challenges with a Focus on the Role of PK/PD Assessments

    Standard Article

    Pharmaceutical Sciences Encyclopedia

    Susan Hurst and Donghua Yin

    Published Online : 30 DEC 2015, DOI: 10.1002/9780470571224.pse557

  7. You have full text access to this OnlineOpen article
    Biosimilar insulins: a European perspective

    Diabetes, Obesity and Metabolism

    Volume 17, Issue 5, May 2015, Pages: 445–451, J. H. DeVries, S. C. L. Gough, J. Kiljanski and L. Heinemann

    Article first published online : 27 NOV 2014, DOI: 10.1111/dom.12410

  8. You have free access to this content
    Biosimilar monoclonal antibodies: A Canadian regulatory perspective on the assessment of clinically relevant differences and indication extrapolation

    The Journal of Clinical Pharmacology

    Volume 55, Issue S3, March 2015, Pages: S123–S132, Bradley J. Scott, Agnes V. Klein and Jian Wang

    Article first published online : 26 JUN 2014, DOI: 10.1002/jcph.339

  9. You have free access to this content
    Biosimilar: what it is not

    British Journal of Clinical Pharmacology

    Volume 80, Issue 5, November 2015, Pages: 949–956, Fernando de Mora

    Article first published online : 4 JUN 2015, DOI: 10.1111/bcp.12656

  10. Scientific considerations for assessing biosimilar products

    Statistics in Medicine

    Volume 32, Issue 3, 10 February 2013, Pages: 370–381, Shein-Chung Chow, Jun Wang, Laszlo Endrenyi and Peter A. Lachenbruch

    Article first published online : 30 AUG 2012, DOI: 10.1002/sim.5571

  11. Biosimilars: how similar?

    Internal Medicine Journal

    Volume 44, Issue 3, March 2014, Pages: 218–223, V. Strand and B. Cronstein

    Article first published online : 13 MAR 2014, DOI: 10.1111/imj.12292

  12. You have full text access to this OnlineOpen article
    Biosimilars 101: considerations for U.S. oncologists in clinical practice

    Cancer Medicine

    Volume 3, Issue 4, August 2014, Pages: 889–899, Luis H. Camacho, Craig P. Frost, Esteban Abella, Phuong K. Morrow and Sadie Whittaker

    Article first published online : 8 MAY 2014, DOI: 10.1002/cam4.258

  13. Analytical strategies for assessing comparability of biosimilars

    Journal of Chemical Technology and Biotechnology

    Volume 86, Issue 7, July 2011, Pages: 915–922, Robert J. Falconer, Dianne Jackson-Matthews and Stephen M. Mahler

    Article first published online : 26 APR 2011, DOI: 10.1002/jctb.2629

  14. You have full text access to this OnlineOpen article
    Biosimilar insulins: guidance for data interpretation by clinicians and users

    Diabetes, Obesity and Metabolism

    Volume 17, Issue 10, October 2015, Pages: 911–918, L. Heinemann, P. D. Home and M. Hompesch

    Article first published online : 1 JUL 2015, DOI: 10.1111/dom.12491

  15. Biosimilars and Their Impact on Biologic LCM

    Pharmaceutical Lifecycle Management: Making the Most of Each and Every Brand

    Tony Ellery, Neal Hansen, Pages: 217–231, 2012

    Published Online : 8 MAY 2012, DOI: 10.1002/9781118266755.ch27

  16. You have full text access to this OnlineOpen article
    Biosimilar agents in oncology/haematology: from approval to practice

    European Journal of Haematology

    Volume 86, Issue 4, April 2011, Pages: 277–288, Dietger Niederwieser and Stephan Schmitz

    Article first published online : 25 JAN 2011, DOI: 10.1111/j.1600-0609.2010.01566.x

  17. You have free access to this content
    Erythropoiesis-stimulating agents for anaemia in adults with chronic kidney disease: a network meta-analysis

    Intervention Review

    The Cochrane Library

    Suetonia C Palmer, Valeria Saglimbene, Dimitris Mavridis, Georgia Salanti, Jonathan C Craig, Marcello Tonelli, Natasha Wiebe and Giovanni FM Strippoli

    Published Online : 8 DEC 2014, DOI: 10.1002/14651858.CD010590.pub2

  18. You have free access to this content
    Cutting-edge mass spectrometry characterization of originator, biosimilar and biobetter antibodies

    Journal of Mass Spectrometry

    Volume 50, Issue 2, February 2015, Pages: 285–297, Alain Beck, François Debaene, Hélène Diemer, Elsa Wagner-Rousset, Olivier Colas, Alain Van Dorsselaer and Sarah Cianférani

    Article first published online : 2 FEB 2015, DOI: 10.1002/jms.3554

  19. You have free access to this content
    Non-Clinical Safety Studies on Biosimilar Recombinant Human Erythropoietin

    Basic & Clinical Pharmacology & Toxicology

    Volume 100, Issue 2, February 2007, Pages: 73–83, Michael J. Parnham, Janice Schindler-Horvat and Marija Kozlović

    Article first published online : 22 JAN 2007, DOI: 10.1111/j.1742-7843.2007.00028.x

  20. Biosimilars

    The Textbook of Pharmaceutical Medicine, 7th Edition

    Raymond A. Huml, John Posner, Pages: 744–750, 2013

    Published Online : 25 APR 2013, DOI: 10.1002/9781118532331.ch38