Monday, October 17, 2011

Evaluation of Similar Biotherapeutic products: Scientific and Regulatory Challenges

Biologicals. Volume 39, Issue 5, Pages 249-358 (September 2011).Copyright © 2011 The International Association for Biologicals. All rights reserved. Publication History: Formerly known as Journal of Biological Standardization. Edited by Elwyn Griffiths, Robin Thorpe, Meenu Wadhwa and Yeowon Sohn.


Evaluation of Similar Biotherapeutic products: Scientific and Regulatory Challenges
Edited by Elwyn Griffiths, Robin Thorpe, Meenu Wadhwa and Yeowon Sohn

 
 
Editorial
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Evaluation of similar biotherapeutic products: Scientific and regulatory challenges
Page 249
Elwyn Griffiths, Robin Thorpe, Meenu Wadhwa, Yeowon Sohn
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Contributors
Page 250
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Acknowledgements
Page 251
I. Background
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Biosimilars – Global issues, national solutions
Pages 252-255
Ivana Knezevic, Elwyn Griffiths
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Evaluation of similar biotherapeutic products (SBPs): Scientific principles and their implementation
Pages 256-261
Ivana Knezevic
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Intended use of Reference Products & WHO International Standards/Reference Reagents in the development of Similar Biological Products (Biosimilars)
Pages 262-265
Robin Thorpe, Meenu Wadhwa
II. Special Lecture
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Statistical considerations for confirmatory clinical trials for similar biotherapeutic products
Pages 266-269
Catherine Njue
III. Case Studies
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Biosimilars clinical development program: Confirmatory clinical trials: A virtual/simulated case study comparing equivalence and non-inferiority approaches
Pages 270-277
Mark P. Fletcher
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The first subsequent entry biologic authorized for market in Canada: The story of Omnitrope, a recombinant human growth hormone
Pages 278-281
Agnes V. Klein
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Reviewing non clinical data for a granulocyte colony stimulatory factor product: Experience in Brazil
Pages 282-283
Laura Gomes Castanheira
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Similar biological medicinal products currently licensed in the European union - Overview of non-clinical study programs
Pages 284-288
Hans-Karl Heim
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Experience of reviewing the follow-on biologics including Somatropin and erythropoietin in Japan
Pages 289-292
Teruyo Arato, Teruhide Yamaguchi
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Clinical programs in the development of similar biotherapeutic products: Rationale and general principles
Pages 293-296
Alexander Berghout
IV. Manufacturer's Perspectives
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A biosimilar industry view on the implementation of the WHO guidelines on evaluating similar biotherapeutic products
Pages 297-299
Martin Schiestl
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An Indian manufacturer’s perspective for harmonization of guidelines for similar biotherapeutic products
Pages 300-303
P.V. Cherish Babu
V. Country Situations
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Summary of the diverse situation of similar biotherapeutic products in the selected countries (August 2010)
Pages 304-307
Hye-Na Kang
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Current development in regulation of similar biotherapeutic products in Brazil
Pages 308-311
Laura Gomes Castanheira, Dirceu Brás Aparecido Barbano, Norberto Rech
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China’s perspective on similar biotherapeutic products
Pages 312-316
Chenggang Liang, Junzhi Wang
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The regulatory framework for similar biotherapeutic products in Cuba
Pages 317-320
Yanet Hechavarría Núñez, Rodrigo Omar Pérez Massipe, Santa Deybis Orta Hernández, Lázara Martínez Muñoz, Olga Lidia Jacobo Casanueva, Violeta Pérez Rodríguez, Rolando Bárbaro Domínguez Morales, Rafael B. Pérez Cristiá
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Biosimilars and non-innovator biotherapeutics in India: An overview of the current situation
Pages 321-324
Hemant Malhotra
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Current regulatory and scientific considerations for approving biosimilars in Iran
Pages 325-327
Naser Hadavand, Mahboubeh Valadkhani, Aida Zarbakhsh
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Quality, safety and efficacy of follow-on biologics in Japan
Pages 328-332
Teruhide Yamaguchi, Teruyo Arato
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Concept of biosimilar products in Jordan
Pages 333-335
Rania Dakhlallah Haddadin
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Regulatory guideline for biosimilar products in Korea
Pages 336-338
Soo Kyung Suh, Younjoo Park
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Regulatory guidelines for biosimilars in Malaysia
Pages 339-342
Arpah Abas
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Registration of similar biological products – Singapore’s approach
Pages 343-345
Jalene Poh, Kai Tong Tam
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Towards regulation of similar biotherapeutic products: Thailand’s perspective
Pages 346-347
Prapassorn Thanaphollert, Kriang Tungsanga
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Biotechnological products in Pan American Health Organization (PAHO): Regional efforts towards harmonization of regulation
Page 348
María L. Pombo
VI. Meeting Report
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WHO/KFDA joint workshop on implementing WHO guidelines on evaluating similar biotherapeutic products, Seoul, Republic of Korea 24–26 August, 2010
Pages 349-357
Meenu Wadhwa, Hye-Na Kang, Ivana Knezevic, Robin Thorpe, Elwyn Griffiths
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Announcement
Page I

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