Directory of Approved Biopharmaceuticals

333 Pages·2004·1.14 MB·English

by  Stefania Spada Gary Walsh

D I R E C T O R Y O F
APPROVED
BIOPHARMACEUTICAL
PRODUCTS

D I R E C T O R Y O F
APPROVED
BIOPHARMACEUTICAL
PRODUCTS
Stefania Spada and Gary Walsh
CRC PR ESS
Boca Raton London New York Washington, D.C.
Warning! This publication is intended for general reference
only and should never be used as a guide for prescribing or
administering the drugs listed.
Cover figure from:
Protein Data Bank (www.rcsb.org/pdb)
PDB ID 1HIG
Ealick, S.E., Cook, W.J., Vijay-Kumar, S., Carson, M., Nagabhushan, T.L., Trotta, P.P., Bugg, C.E.
Three-Dimensional Structure Recombinant Human Interferon-Gamma.
Science 252 pp. 698 (1991)
Library of Congress Cataloging-in-Publication Data
Spada, Stefania.
Directory of approved biopharmaceutical products / by Stefania Spada and Gary Walsh.
p. ; cm.
Includes bibliographical references.
ISBN 0-415-26368-9 (alk. paper)
1. Protein drugs—Catalogs. 2. Nucleic acids—Therapeutic use—Catalogs. I. Walsh,
Gary, Dr. II. Title.
[DNLM: 1. Nucleic Acids—therapeutic use—Catalogs. 2. Pharmaceutical
Preparations—Catalogs. 3. Proteins—therapeutic use—Catalogs. QV 772 S732d 2004]
RS431.P75S635 2004
615′.19--dc22 2004050317
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We dedicate this book to our families —
Gerard, Cristina, Maria, Nancy, Eithne, and Shane

Preface
The term "biopharmaceutical" has become an accepted part of the pharma-
ceutical vocabulary. It refers to therapeutic proteins produced by genetic
engineering (or via hybridoma technology, in the case of some monoclonal
antibodies), as well as nucleic acid-based products. By mid-2003, some 118
biopharmaceutical products had gained marketing approval and one in
approximately every four genuinely new drugs coming on the market are
now produced by biotechnological means.
Despite the prominence of biopharmaceuticals in the modern pharmaceu-
tical era, relatively few publications focus, to any meaningful extent, on
actual commercial products. This book aims to do just that — to provide a
brief summary of each biopharmaceutical product approved for medical use.
Product information is provided in monograph format. We have attempted
to keep the profiles relatively consistent throughout the directory; however,
some variations occur due to the information available from primary liter-
ature reference sources. The majority of information provided has been
sourced from regulatory Web sites, including the European Medicines Eval-
uation Agency (EMEA) and the U.S. Food and Drug Administration (FDA),
as well as from the Web sites of relevant pharmaceutical companies. Avail-
ability only within the E.U. and U.S. is discussed, although many of the
listed products have also gained approval in other world regions. Approvals
listed for E.U. products refer specifically to products approved through the
new, centralized European drug approval system, introduced in 1995. Some
products (particularly earlier products, such as recombinant human growth
hormone preparations) gained approval in some European countries prior
to 1995 and are still available in those countries.
As authors, we have ensured to the best of our ability that all the infor-
mation provided is accurate. This directory, however, is intended as a general
reference only and should never be used as a guide for prescribing or admin-
istering the drugs listed. Updated information (e.g., modified indications,
safety warnings, etc.) on any of the drugs can be obtained by consulting the
Web sites of the relevant regulatory authorities or the companies that market
the products.
This directory is aimed primarily at individuals employed within the
biopharmaceutical sector and at those with an interest in this sector and the
products it produces. It will also serve as a useful reference for students
pursuing courses in biotechnology, medicine, pharmacy, or pharmaceutical
science.

Authors
Stefania Spada obtained a degree in biological sciences from the University
of Milan, Italy. She engineered antibodies for carcinoma therapy at the
Department of Biological and Technological Research, in the San Raffaele
Scientific Institute in Milan. While working on her Ph.D. in biochemistry at
the University of Zurich, Switzerland, she developed a novel phage dis-
play-based system of selection of interacting ligand pairs. Spada held a
postdoctoral position at the University of Limerick, Ireland, where she iden-
tified and characterized proteins with novel biotechnological properties from
thermophilic bacteria.
Gary Walsh obtained his Ph.D. from the National University of Ireland at
Galway. He worked in the pharmaceutical and biotechnology industries for
a number of years and is a senior lecturer of biotechnology at the University
of Limerick. Walsh has published numerous articles and books on various
aspects of pharmaceutical biotechnology. He sits on the editorial board of
two international pharmaceutical journals and is scientific secretary of the
European Association of Pharma Biotechnology.