Marketed recombinant proteins administration

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... 

The biotechnology industry has evolved significantly since the introduction in 1982 of human insulin synthesized in Escherichia coli—the first Food and Drug Administration (FDA)-approved recombinant therapeutic agent in the United States. Since then, over 75 other recombinant proteins have been introduced. The list is comprised of cytokines, hormones, monoclonal antibodies, and vaccines. There are more than 1100 companies competing for this market, and the current sale of these products comprises approximately 10% of the sales of all therapeutic products sold in the United States. One such product, erythropoietin, an erythropoiesis-stimulating factor also known... 

In January 2004, The Market Health Products Directorate (MHPD) of the Health Products and Food Branch (HPFB) posted some information in regards to this situation. Janssen-Ortho Inc., consulted with Health Canada and revised their prescribing information. They mentioned that Eprex was supplied in two formulations with different stabilizers, one containing polysorbate-80 and the other containing human serum albumin (HSA). It also cautioned that subcutaneous administration of recombinant human proteins may in-... 

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