Journal of Biopharmaceutical Statistics, 24: 1137, 2014 Copyright © Taylor & Francis Group, LLC ISSN: 1054-3406 print/1520-5711 online DOI: 10.1080/10543406.2014.948551
PREFACE Bin Yao1 and Eric Chi2 1 2
Puma Biotechnology, Los Angeles, California, USA Amgen, Inc., Thousand Oaks, California, USA
We are pleased to present the November issue of the Journal of Biopharmaceutical Statistics as a special issue entitled “Issues in Biosimilar Drug Development.” The development of biosimilar products has garnered significant attention in recent years from stakeholders in the industry, academia, regulatory authorities, payers, health care providers, and patient groups. Guidance documents from the European Medicines Agency (EMA), Food and Drug Administration (FDA), and World Health Organization (WHO) have stimulated a great deal of research, discussions, and debates. It is our hope that the special issue will contribute to the ongoing dialogues and will make a good reference material for practitioners at the forefront of the biosimilar drug development. The contributions contained in this special issue exemplify the interest, breadth, diversity, and in some instances, controversies of the rapidly evolving field of biosimilar drug development. The 15 peer-reviewed articles provide readers with both a broad overview of relevant topics and a sampling of the innovative research seeking to improve our capabilities to deal with the conceptual and real-world issues. It is these valuable ideas and research that will help pave the way for progress to ensure that a science-based and patient-focused approach will be adopted to bring safe and effective biosimilar products to market. We thank all authors who contributed their papers and are grateful to the editor-inchief, Dr. Chow, for making possible the special issue. We are also indebted to the Journal of Biopharmaceutical Statistics publishing and production teams for their assistance in preparation and publication of this special issue.
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Copyright of Journal of Biopharmaceutical Statistics is the property of Taylor & Francis Ltd and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use.
PREFACE Bin Yao1 and Eric Chi2 1 2
Puma Biotechnology, Los Angeles, California, USA Amgen, Inc., Thousand Oaks, California, USA
We are pleased to present the November issue of the Journal of Biopharmaceutical Statistics as a special issue entitled “Issues in Biosimilar Drug Development.” The development of biosimilar products has garnered significant attention in recent years from stakeholders in the industry, academia, regulatory authorities, payers, health care providers, and patient groups. Guidance documents from the European Medicines Agency (EMA), Food and Drug Administration (FDA), and World Health Organization (WHO) have stimulated a great deal of research, discussions, and debates. It is our hope that the special issue will contribute to the ongoing dialogues and will make a good reference material for practitioners at the forefront of the biosimilar drug development. The contributions contained in this special issue exemplify the interest, breadth, diversity, and in some instances, controversies of the rapidly evolving field of biosimilar drug development. The 15 peer-reviewed articles provide readers with both a broad overview of relevant topics and a sampling of the innovative research seeking to improve our capabilities to deal with the conceptual and real-world issues. It is these valuable ideas and research that will help pave the way for progress to ensure that a science-based and patient-focused approach will be adopted to bring safe and effective biosimilar products to market. We thank all authors who contributed their papers and are grateful to the editor-inchief, Dr. Chow, for making possible the special issue. We are also indebted to the Journal of Biopharmaceutical Statistics publishing and production teams for their assistance in preparation and publication of this special issue.
1137
Copyright of Journal of Biopharmaceutical Statistics is the property of Taylor & Francis Ltd and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use.
