Biologics include a wide range of medicinal products such as vaccines, blood and blood components, allergenics, somatic cells, gene therapy, tissues, and 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.
See also biosimilars
Unlike the more common "small-molecule" drugs, biologics generally exhibit high molecular complexity, and may be quite sensitive to manufacturing process changes. The follow-on manufacturer does not have access to the originator's molecular clone and original cell bank, nor to the exact fermention and purification process. Finally, nearly undetectable differences in impurities and/or breakdown products are known to have serious health implications. This has created a concern that generic versions of biologics might perform differently than the original branded version of the drug. So, unlike most drugs, generic versions of biologics are not authorized in the US or the European Union through the simplified procedures allowed for small molecule generics. In the EU a specially-adapted approval procedure has been authorized for certain protein drugs, termed "similar biological medicinal products". This procedure is based on a thorough demonstration of "comparability" of the "similar" product to an existing approved product. In the US the FDA has taken the position that new legislation will be required to address these concerns. Additional Congressional hearings have been held, but no legislation had been approved as of May 2007.
A few examples of biologics made with recombinant DNA technology include:
|USAN/INN||Trade Name||Indication||Technology||Mechanism of Action|
|abatacept||Orencia®||rheumatoid arthritis||immunoglobin CTLA-4 fusion protein||T-cell deactivation|
|adalimumab||Humira®||rheumatoid arthritis||monoclonal antibody||TNF antagonist|
|alefacept||Amevive®||chronic plaque psoriasis||immunoglobin G1 fusion protein||incompletely characterized|
|erythropoietin||Epogen®||anemia arising from cancer chemotherapy, chronic renal failure, etc.||recombinant protein||stimulation of red blood cell production|
|etanercept||Enbrel®||Rheumatoid arthritis, ankylosing spondylitis, psoriasis||recombinant human TNF-receptor fusion protein||TNF antagonist|
|infliximab||Remicade®||Crohn's disease||monoclonal antibody||TNF antagonist|
|trastuzumab||Herceptin®||breast cancer||humanized monoclonal antibody||HER2/neu (erbB2) antagonist|
- ↑ FDA, CBER Frequently Asked Questions
- ↑ EMEA Guideline on Similar Biological Medicinal Products, CHMP/437/04 London, 30 October 2005
- ↑ US Senate Committee on the Judiciary, Testimony of Dr. Lester Crawford, Acting Commissioner, FDA June 23, 2004
- ↑ [http://energycommerce.house.gov/cmte_mtgs/110-he-hrg.050207.Biosimilar.shtml Hearing: Assessing the Impact of a Safe and Equitable Biosimilar Policy in the United States. Subcommittee on Health Wednesday, May 2, 2007]
- Why are biogenerics so hard to regulate?
- Guide to Biotechnology, Biotechnology Industry Organization
- Generic Biologics: The Next Frontier
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