Biologia

Biologics include a wide range of medicinal products such as vaccines, blood and blood components, allergenics,[1] somatic cells, gene therapy, tissues, and recombinant therapeutic proteins createdby biological processes (as distinguished from chemistry).

Biologics can be composed of sugars, proteins, or nucleic acids or complex combinations of these substances, or may be living entities suchas 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 technologies. Gene-based andcellular 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.[2]

In somejurisdictions, biologics are regulated in a different manner than are drugs and medical devices.[3]

Contents [hide]
1 Recombinant DNA biologics
1.1 EU version:
2 Biosimilars
3 Examples
4 Seealso
5 References
6 External links

[edit] Recombinant DNA biologics
As indicated above, the term "biologics" can be used to refer to a wide range of biological products in medicine. However, inmost cases, the term "biologics" is used more restrictively for a class of medications (either approved or in development) that are produced by means of biological processes involving recombinant DNAtechnology. These medications are usually one of three types:

1.Substances that are (nearly) identical to the body's own key signalling proteins. Examples are the blood-production stimulatingprotein erythropoetin, or the growth-stimulating hormone named (simply) "growth hormone".
2.Monoclonal antibodies. These are similar to the antibodies that the human immune system uses to fight offbacteria and viruses, but they are "custom-designed" (using hybridoma technology or other methods) and can therefore be made specifically to counteract or block any given substance in the body, or to...