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Biologics



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.[1]

Additional recommended knowledge

Contents

Biologics

As indicated above, the term "biologics" can be used to refer to a wide range of biological products in medicine. However, in most 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 DNA technology. 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 stimulating protein 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 off bacteria 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 target any specific cell type; examples of such monoclonal antibodies for use in various diseases are given in the table below.
  • 3) Receptor constructs (fusion proteins), usually based on a naturally-occurring receptor linked to the immunoglobulin frame. In this case, the receptor provides the construct with detailed specificity, whereas the immunoglobulin-structure imparts stability and other useful features in terms of pharmacology. Some examples are listed in the table below.

Biologics as a class of medications in this narrower sense have had a profound impact on many medical fields, primarily rheumatology and oncology, but also cardiology, dermatology, gastroenterology, neurology, and others. In most of these disciplines, biologics have added major therapeutic options for the treatment of many diseases, including some for which no effective therapies were available, and others where previously existing therapies were clearly inadequate. However, the advent of biologic therapeutics has also raised complex regulatory issues (see below), and significant pharmacoeconomic concerns, because the cost for biologic therapies has been dramatically higher than for conventional (pharmacological) medications. This factor has been particularly relevant since many biological medications are used for the treatment of chronic diseases, such as rheumatoid arthritis or inflammatory bowel disease, or for the treatment of otherwise untreatable cancer during the remainder of life. The cost of treatment with a typical monoclonal antibody therapy for relatively common indications is generally in the range of € 7,000-14,000 per patient per year.

Biosimilars

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.[2] 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.[3] In the US the FDA has taken the position that new legislation will be required to address these concerns.[4] Additional Congressional hearings have been held,[5] but no legislation had been approved as of May 2007.

Examples

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, ankylosing spondylitis, psoriatic 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, psoriatic arthritis, psoriasis recombinant human TNF-receptor fusion protein TNF antagonist
infliximab Remicade® rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, psoriasis, Crohn's disease monoclonal antibody TNF antagonist
trastuzumab Herceptin® breast cancer humanized monoclonal antibody HER2/neu (erbB2) antagonist

See also

References

  1. ^ Center for Biologics Evaluation and Research (2007-10-29). What is a biological product?. U.S. Food and Drug Administration. Retrieved on 2007-12-17.
  2. ^ Roger SD, Mikhail A (2007). "Biosimilars: opportunity or cause for concern?". J Pharm Pharm Sci 10 (3): 405–10. PMID 17727803.
  3. ^ Committee for Medicinal Products for Human Use (CHMP) (2005-10-30). Guideline on Similar Biological Medicinal Products. European Medicines Agency. Retrieved on 2007-12-17.
  4. ^ Dr. Lester Crawford (2005-10-30). Testimony of Dr. Lester Crawford, Acting Commissioner, Food and Drug Administration. United States Senate, Committee on the Judiciary. Retrieved on 2007-12-17.
  5. ^ Janet Woodcock, M.D. (2007-05-02). Assessing the Impact of a Safe and Equitable Biosimilar Policy in the United States. United States House of Representatives, Committee on Energy and Commerce. Retrieved on 2007-12-17.
 
This article is licensed under the GNU Free Documentation License. It uses material from the Wikipedia article "Biologics". A list of authors is available in Wikipedia.
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