A Biologics FAQ
Erica Sanderson | Nov 21, 2014 Nov 17, 2016
What are biologics?
Biologics are a class of inflammatory bowel disease (IBD) drugs that target agents of the immune response that cause inflammation, such as tumor necrosis factor alpha (TNF-alpha). Biologic agents are genetically engineered from living organisms. They release antibodies to attach to substances that trigger inflammation in the body, such as enzymes and proteins.
Who can take biologics?
Patients with moderate to severe IBD. New research is starting to show biologics may help earlier on in treatment—not only as an option after other conventional treatments fail. Patients should be screened for infections prior to starting biologics to reduce potential risk. People with tuberculosis, heart failure, or multiple sclerosis should not take biologics.
What are the side effects?
Since biologics suppress the immune system, there are a range of potential side effects, most notably infections. These types of infections include urinary and upper respiratory. In rare cases, increased risk of cancer has been reported. Other common side effects include rash, nausea, headache, pain or swelling at injection site, hives and fever. If you experience any side effects, speak to your doctor.
How effective are they?
How well someone responds to biologics varies by person. In general, people with more severe stages of IBD have experienced very positive results from using biologics. They have been proven to obtain and maintain remission in some patients. However, biologics may not work for everyone. Speak to your doctor to learn more.
Do biologics increase the risk of cancer?
In some instances, the use of biologic drugs may increase the risk of getting certain cancers. Studies have, for instance, shown an increased risk of developing non-Hodgkin’s lymphoma and skin cancer. However, the risk of getting cancer due biologics treatment is still small and should be weighed against the potential benefits.
How are biologics different from regular drugs?
While drugs are made from chemical substances within known structures, biologics are more complex mixtures. They’re heat-sensitive and can be contaminated by bacteria so the manufacturing process is different as well. Inside the body, biologics target specific parts of the immune system whereas traditional medications affect the entire immune system.
Who regulates biologics?
In the U.S., The Food and Drug Administration is in charge of reviewing, approving and the oversight of biologic drugs. Companies who develop, manufacture and distribute biologics must meet the requirements established by either the FDA’s Center for Drug Evaluation and Research (CDER) or the Center for Biologics Evaluation and Research (CBER).
How much do biologics cost?
Biologics are relatively expensive compared to other drugs. As a newer class of treatment, costs to make the drug can be high due to the the complexity involved in manufacturing. There are also no generic alternatives. Biologic drugs for rheumatoid arthritis, for instance, cost about $1,000 to $3,000 a month, according to WebMD. The drugs are often covered by insurance though so check with your provider.