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
| 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 | ||||
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I. Background
| 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 | ||||
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II. Special Lecture
| Statistical considerations for confirmatory clinical trials for similar biotherapeutic products Pages 266-269 Catherine Njue | ||||
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III. Case Studies
| 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 | ||||
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IV. Manufacturer's Perspectives
| 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 | ||||
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V. Country Situations
| 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 | ||||
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VI. Meeting Report
| 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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