Biological therapy

Biological drugs represent medical drugs produced by biotechnology that include biological macromolecules such as nucleic acids, proteins or microorganisms. Since the biosynthetic human insulin made 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 a vast array of diseases. Protein based products are expected to be 4 out of 5 top-selling drugs on the global market by the end of 2013. The estimated global market value for biologicals is 90 billion dollars, which represents 13,8 % of all pharmaceutics. Biological drugs can be used in almost any field of medicine but are mainly restricted to several diseases, such as cancer, autoimmune diseases, infectious diseases, AIDS/HIV, diabetes and cardiovascular diseases.

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

Once prescribed to treat only rare genetic diseases, biologics have rapidly become a more common therapeutic option for different disease conditions. There are numerous advantages of biologics over non-biologics, especially for chronic diseases such as arthritis, where biologics can provide much better long-term outcomes. Some examples of biologics on the market are antibodies such as TNFR in arthritis therapy or HER2/neu in breast cancer, interferon alpha used for the induction of antiviral response and insulin which is indispensable in diabetes therapy. The use of biopharmaceuticals often leads to faster recovery and can reduce the amount of additional therapy needed. 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 in a safe and efficient manner that has not been possible before (e.g. hemophilia, growth hormone…). In general biologic therapy is more efficient in treating many chronic diseases than its traditional counterparts as it is not palliative and focused simply on symptom control but acts on the pathways that represent the core of the disease.

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