Book Review: Biopharmaceutical Products in the US and European Markets 6th edition (2 volumes)

Author: Ronald A. Rader

Publishers: BioPlan Associates, Inc.

Published: September 2007

I groaned slightly when this work initially landed on my desk—at 1,600 pages over 2 volumes—it felt I had bitten off more than I could comfortably chew! Having read the introductory sections in full and having dipped in and out of the product monographs I would, however, classify this publication as a useful, comprehensive, and truly an excellent reference source of biopharmaceutical information.

The first 100 or so pages feature a collection of commentaries, articles, and datasets that provide an excellent overview of the sector and where it is going. The specific issues considered include an overview of recent and upcoming product approvals, global market size and profile, blockbuster products, market and industry trends, and technical developments relating to, for example, expression systems used for biopharmaceutical manufacture. Also included are a number of incisive and well-researched articles focusing on a variety of topics including biogeneric/biosimiliar products and their potential.

The remainder of the publication is predominantly taken up by some 510 individual product monographs, grouped into categories of recombinant DNA-derived and monoclonal antibody-based products (volume 1), as well as vaccines and blood products, toxins, enzymes, traditional insulins, and cultured cell and tissue products (volume 2). At the end of volume 2, various useful appendices are presented summarizing, for example, lists of FDA approved biologics and biologics establishments. Following this are various indexes that allow one to quickly find products categorized in a range of different ways.

The collection of product monographs forms the backbone of the publication, collectively taking up some 850 pages of text. Each monograph provides a comprehensive overview of its target product, listing information including names, regulatory and market status, product description, uses, and history. Also included is information related to manufacturing, markets, patents, competition, and cost, as well as ongoing trials, pending filings, and any follow-on research and development.

The book is very clearly laid out and intuitive to use. It is also professionally finished and comes with a freely accessible web site (www.biopharma.com). Although the main focus of the web site seems to be to market the book itself, partial product information can be obtained therein at no cost.

The publication is a comprehensive and fantastic resource. It would be particularly useful to professionals working in the biopharmaceutical sector or regulatory agencies, or as bio-business analysts. The publication would also make a wonderful addition to the library of any university.

The two-volume set costs $745, which is not cheap. However, it costs no more than the registration fees typical of many scientific conferences and, for most, it will prove more useful than any conference proceedings.

I found very few weak points in this publication. Apart from its cost it does have a slight American bias, mainly in the initial overview and commentary sections, in which issues such as summary overviews of recent approvals, market size data, etc., have more of an American focus. This, however, does not detract from the publication in any significant way. I highly recommend this publication to all.

Gary Walsh, is an associate professor in the Industrial Biochemistry Program at the University of Limerick, Limerick City, Ireland, +353.61.202664, gary.walsh@ul.ie He is also a member of BioPharm International's editorial advisory board.