New Biologic drugs have recently been approved by the FDA for use in moderate to severe asthma and for chronic urticaria. The biologic drug Xolair was first approved by the FDA for use in asthma in 2003. Xolair was approved for use in chronic hives (chronic urticaria) in 2014. The biologic drug Nucala was approved by the FDA in 2015 for use in severe asthma.
What is a biological product?
A biologic medication is manufactured in a living system such as a microorganism, or plant or animal cells. Most biologics are very large, complex molecules or mixtures of molecules. Many biologics are produced using recombinant DNA technology. Biological products include a wide range of products including recombinant therapeutic proteins. Biologics can be composed of sugars, proteins, or nucleic acids or complex combinations of these substances, or may be living entities such as cells and tissues. Biologics are isolated from a variety of natural sources - human, animal, or microorganism - and may be produced by biotechnology methods and other cutting-edge technologies. Gene-based and cellular biologics, for example, often are at the forefront of biomedical research, and may be used to treat a variety of medical conditions for which no other treatments are available.
How do biological products differ from conventional drugs?
A biologic is manufactured in a living system such as a microorganism, or plant or animal cells. Most biologics are very large, complex molecules or mixtures of molecules. Many biologics are produced using recombinant DNA technology.
A conventional drug is typically manufactured through chemical synthesis, which means that it is made by combining specific chemical ingredients in an ordered process.
Drugs generally have well-defined chemical structures, and a finished drug can usually be analyzed to determine all its various components. By contrast it is difficult, and sometimes impossible, to characterize a complex biologic by testing methods available in the laboratory, and some of the components of a finished biologic may be unknown.
Biological products often represent the cutting-edge of biomedical research and, in time, may offer the most effective means to treat a variety of medical illnesses and conditions that presently have no other treatments available