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Biologic drugs are medications originating in living systems like microorganisms, animals, or humans. The technology for producing biologic drugs can include things like recombinant DNA, monoclonal antibodies, and other techniques for stimulating a living organism to produce a reliable supply of a compound. Doctors use these drugs in a variety of settings, ranging from cancer treatment to diabetes management.
A wide variety of products including hormones, blood components, and antibodies are all considered biologic drugs. A doctor may prescribe a biologic drug for management of acute or chronic disease. As the patient takes the drug, the doctor will order tests to see if the patient's body is responding to the medication. Monitoring for side effects also takes place to identify complications like allergies or other physical reactions to a biologic drug.
One key difference between biologic drugs and synthetic drugs is the manufacturing technique. When a manufacturer produces a synthetic drug, a series of controlled chemical reactions produce a synthetic compound with known properties. The process is highly reliable and stable. With a biologic drug, manufacturers rely on manipulation of living cells, and the process requires careful controls to keep the output as reliable as possible. The full chemical formula and structure of such drugs may not be known, and small variations in manufacturing processes could lead to radical differences in drug performance, an issue when it comes to producing generic versions.
The manufacturing process for a biologic drug tends to be expensive and such drugs can have a very high price tag. Making biologic drugs affordable to consumers is a concern among some governments, as well as drug companies. Some of these drugs are the best treatments available for disease, including historically fatal diseases. With high prices, only people with excellent insurance coverage or deep pockets can afford biologic treatments, especially in the case of drugs that primarily extend life, rather than having a curative effect.
When a doctor recommends a biologic drug for treatment, patients can ask about available alternatives and the prognosis with various treatment options. If there are concerns about affordability, the situation can be discussed with the doctor. Some drug companies offer compassionate use medications to patients with financial needs. An insurance company may also cover a drug if a doctor can demonstrate that it is the most appropriate or only available treatment. Patients may also have access to these drugs through clinical trials, where the medication will be provided at no cost.