Biotechnology approved products

Over the past two decades many biotechnology-derived products have been approved in the United States. A selected list of these products is provided in Table 6.2. The products include recombinant endogenous-replacement proteins, cytokines, monoclonal antibodies, and fusion molecules. Other chapters in this book give more detailed product-class-specific descriptions of the preclinical development programs for many of these molecules. 

Different problems are encountered for approval of copies of bio technologically derived products. The issue is of practical relevance as the patent of many biological products has or is going to expire. Biotechnology derived products may represent a... 

BLA system may be the future marketing approval model for submission of all biotechnology-derived products. 

Center for Biologies Evaluation and Research (CBER). This center is responsible for the regulation and approval of ah biological products intended for use in the treatment, prevention, or cure of diseases or injuries to humans. A biological product is any vims, therapeutic semm, toxin, antitoxin, vaccine, blood or blood component or derivative, or analogous product (5). It also includes products produced by biotechnology, such as interferons and erythropoietins. 

The first of these can be used when a product is to be marketed in a single country. It can be used for any type of application except for certain types of biotechnology-based items. Having been approved in one country, in most cases an application to a second country will trigger the Mutual Recognition procedure in other concerned countries. There are certain exceptions to this, e.g., where a product has different summaries of product characteristics (SmPCs) in different countries, and these have not been subjected to a harmonization procedure. Line extensions to such products could also remain subject to national procedures. 

After the approval of the first product, recombinant insulin, in 1982, progress in the development of new recombinant protein pharmaceuticals was slow ([10], Fig. 17.1). The number of biotechnology-derived drugs and vaccines approved by the US Food and Dmg Administration (FDA) has increased significantly only since 1995. More recently, sales of biologies have skyrocketed, e.g. from 900 million in 1999 to an estimated 3.5 billion in 2001 for monoclonal antibodies [11]. The annual global market for biopharmaceuticals is estimated to have increased from 12 billion US to 30 billion US in 2003 [12]. 500 candidate biopharmaceuticals are undergoing clinical evaluation and over one hundred protein-based therapeutics are in the... 

Almost all products of modern pharmaceutical biotechnology, be they on the market or likely to gain approval in the short to intermediate term, are protein based. As such, an understanding of protein structure is central to this topic. A comprehensive treatment of the subject would easily constitute a book on its own, and many such publications are available. The aim of this chapter is to provide a basic overview of the subject in order to equip the reader with a knowledge of protein science sufficient to understand relevant concepts outlined in the remaining chapters of this book. The interested reader is also referred to the Further reading section, which lists several excellent specialist publications in the field. Much additional information may also be sourced via the web sites mentioned within the chapter. 

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