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Biological therapy

Biological drugs represent important medical tools produced by biotechnology that include nucleic acids or proteins. Since the approval of biosynthetic human insulin produced via recombinant DNA technology in 1982 as the first substance approved for therapeutic use, there are currently more than 160 registered biological drugs approved for therapy. Due to their high specificity and efficiency, biological drugs are rapidly becoming a standard therapy for numerous diseases. Protein based products are expected to account for 4 out of 5 top-selling drugs worldwide by the end of 2013. The global market value for biologicals is estimated at 90 billion dollars, which represents 13,8 % of all pharmaceuticals. Biological drugs can be used in almost any field of medicine but are mainly restricted to diseases such as cancer, autoimmune diseases, infectious diseases, AIDS/HIV, diabetes and cardiovascular diseases (Figure 1).

Figure 1. Top 10 classes of pharmaceuticals in clinical use (source of data: IMS Health).

There are numerous advantages of biological drugs over non-biologics, especially for chronic diseases such as arthritis, where biologics can provide much better long-term outcomes. Some examples of biologics in clinical use are antibodies such as TNFR in therapy of arthritis or HER2/neu in breast cancer therapy., Others include small proteins such as interferon alpha used for the induction of antiviral response and insulin which is indispensable in therapy of diabetes. The use of biopharmaceuticals often leads to faster recovery and can reduce the need for additional therapy. With the use of biologics we are able to replace a protein or a hormone that is missing or is down-regulated in a patient (e.g. blood clotting factors, growth hormone…) in a safe and efficient manner that has not been possible before. In general, biologic therapy is more efficient for treatment of many chronic diseases than traditional drugs as it is not palliative and focused simply on the symptom control but acts on pathways that represent the underlying cause of the disease.

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