Biologics

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Biologics or biologic therapies are a new class of drugs produced through genetic manipulation. They include standard single molecule drugs, as well as antibodies and vaccines. They are mostly produced using cell culture.

According to Christopher Webster et al^[1], a biologic is a prophylactic, an in vivo diagnostic, or a therapeutic substance that can be made only by a living system and that has a large, complex, inherently heterogeneous molecular structure.

Biologics include Amevive®, etanercept (Enbrel®), Humira®, infliximab (Remicade®) and Raptiva. These act as immunosuppressants by blocking the inflammation causing action of TNF-alpha.

These drugs have only recently begun to receive approval by the US FDA.

[edit] Reference

^ Webster, C., Copmann, T., Garnick, R., Green, J., Hayes, M., Landis, J., Lubiniecki, A., Murano, G., Seamon, K., Zezza, D. and Gillian R. Woollett. "Biologics: Can There Be Abbreviated Applications, Generics, or Follow-On Products?". BioPharm International (July 1, 2003). Retrieved on 2006-11-24.