Produced By Recombinant DNA
As indicated 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 therapeutics (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:
- 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" or biosynthetic human insulin and its analogues.
- 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.
- 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.
Older patients who receive biologic therapy for diseases such as rheumatoid arthritis, psoriatic arthritis, or ankylosing spondylitis are at increased risk for life-threatening infection, adverse cardiovascular events, and malignancy. However, because other therapies are often ineffective, biologic therapy should be considered for some of these patients.
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, psoriasis, Crohn's disease | 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 |
| ustekinumab | Stelara | psoriasis | humanized monoclonal antibody | |
| denileukin diftitox | Ontak | cutaneous T-cell lymphoma (CTCL) | Diphtheria toxin engineered protein combining Interleukin-2 and Diphtheria toxin | Interleukin-2 receptor binder |
Read more about this topic: Biologic Medical Product, Major Classes
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—William Gibson (b. 1948)