Biopharmaceuticals approved products

Current Status of Biopharmaceuticals Approved Products and Trends in Approvals... 

I Current Status of Biopharmaceuticals Approved Products and Trends in Approvals Tables Recombinant hemopoietic growth factors approved for general medical use... 

Table 1.3 Selected engineered biopharmaceutical types/products that have now gained marketing approval. These and additional such products will be discussed in detail in subseguent chapters...

Many of the initial biopharmaceuticals approved were simple replacement proteins (e.g. blood factors and human insulin). The ability to alter the amino acid sequence of a protein logically coupled to an increased understanding of the relationship between protein structure and function (Chapters 2 and 3) has facilitated the more recent introduction of several engineered therapeutic proteins (Table 1.3). Thus far, the vast majority of approved recombinant proteins have been produced in the bacterium E. coli, the yeast S. cerevisiae or in animal cell lines (most notably Chinese hamster ovary (CHO) cells or baby hamster kidney (BHK) cells. These production systems are discussed in Chapter 5. 

Although most biopharmaceuticals approved to date are intended for human use, a number of products destined for veterinary application have also come on the market. One early such example is that of recombinant bovine GH (Somatotrophin), which was approved in the USA in the early 1990s and used to increase milk yields from dairy cattle. Additional examples of approved veterinary biopharmaceuticals include a range of recombinant vaccines and an interferon-based product (Table 1.7). 

For an extended-release dosage form, at least three test time points are chosen to characterize the in vitro drug-release profile for the routine batch-to-batch quality control for approved products. Additional sampling times may be required for formulation development studies, biopharmaceutical evaluations, and drug approval purposes. An early time... 

In the development of new biopharmaceutical molecules, there is a constant need for analytical methods that provide critical information in areas that range from early characterization to routine analysis of approved products. Past experience indicates there are few projects in drug development that can be addressed by standard analytical procedures. Even well-established techniques often have to be modified to better suit the analysis of new samples. For this reason, a broad range of techniques is already an integral part of laboratories in the biopharmaceutical industry. 

Amongst the limited number of biopharmaceuticals approved for animal use (Chapter 1), recombinant vaccines represent the single largest sub-group. Several such products target pigs,... 

EMEA home page. A key reference for regulatory issues (European) for biopharmaceutical development and production. Also contains information on approved products. 

Examples of product class carcinogenicity hazard identifications and assessments and ultimate risk communications for biopharmaceuticals approved in the United States for chronic use or based on potential cause for concern are provided in Table 19.4a (products without carcinogenicity assessment) and Table 19.4b (products with carcinogenicity assessment). The data are derived from publicly available regulatory assessments and product labels. Specific examples are discussed below. 

Vitravene (fomivirsen sodium, ISIS Pharmaceuticals see Table 9) remains the only antisense-based biopharmaceutical approved for general medical use (see also Part III, Chapter 3). The product is a 21-base phosphorothioate nucleotide that displays a base sequence complementary to certain human cytomegaloviral mRNA transcripts. Its administration inhibits viral replication through an antisense mechanism. Approved in the US in 1998 and in the EU in 1999, the product is indicated for the treatment of cytomegalovirus retinitis by intraocular injection in AIDS patients. It was withdrawn from the EU market in May 2002 for commercial reasons. 

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