Simply stated, this book/database covers all contemporary products in the U.S. and European markets generally considered to be human biopharmaceutical products 'Biopharmaceuticals" refers to complex biological products manufactured by biotechnology methods/processes (generally involving live biological components/organisms; bioprocessing). Like "biotechnology," "biopharmaceuticals" is much easier to identify on a case-by-case basis than to try and define. "Biopharmaceuticals" is used much as the term "drugs" is often used to refer to pharmaceuticals (chemical substances) manufactured/derived by chemical methods.

See the author's two-part series of articles, "What is a Biopharmaceutical?," Part 1: (Bio)Technology-Based Definitions and Part 2: Company and Industry Definitions

Coverage includes all biotechnology-derived products currently or recently approved by FDA or in Europe (EU or European countries) for therapeutic indications or used in vivo, e.g., radiolabeled monoclonal antibody radiodiagnostics. This includes all microorganism and animal cell and tissue-derived proteins, vaccines, blood products, antibodies, enzymes, cytokines, radioimmune conjugates and certain engineered tissue grafts/implants.

Products are included irrespective of whether they involve old (e.g., fermentation) or new (e.g., recombinant DNA, monoclonal antibody) biotechnologies. Note, coverage includes vaccines and blood products, often not considered as biopharmaceuticals by others who restrict their use of the term to recombinant proteins and monoclonal antibody-based products.

Coverage includes biopharmaceuticals irrespective of their regulation as biologics, drugs, or medical devices. Most of the products covered are biologics. Products regulated as drugs (e.g., recombinant versions of certain hormones, enzymes and natural products) and medical devices (e.g., recombinant sutures) are also included.

Coverage does not include products generally considered to be (and often regulated as) drugs/chemical substances, such as antibiotics (although most are produced by biotechnology methods), botanicals, and other natural products.

Please inform us of any products that should be in the database.

1. Title/Heading
2. Main Names
3. Cross References
4. Company Summary/Links
5. Product Description
6. Nomenclature
7. History
8. Companies/Establishments
9. Manufacture
10. Approvals
11. Approved Indications
12. Regulatory/Marketing Status
13. FDA Product Class
14. FDA CBER Class
15. Patents/Technology Transfer
16. Biological Activity
17. Clinical Trials
18. Medical/Use
19. Disease/Epidemiology Aspects
20. Competing Products
21. Marketing/Sales
22. Ongoing Development
23. References
24. [Indexing fields - nomenclature, biological, chemical, medical, regulatory, etc.]

Monographs include all on-hand publishable information, placed within fields/sections for the sake of ease of presentation and understanding. Every product monograph is handled independently, with no forcing of division of complex, intricately-related information into fields/sections. Thus, various types of information may be found in other fields/sections (e.g., some biological activity information may be discussed in the Description). The length of sections and product monographs varies greatly.