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What is a biologic drug (biologics)?

  • A biologic drug (biologics) is a product that is produced from living organisms or contain components of living organisms.
  • Biologic drugs include a wide variety of products derived from human, animal, or microorganisms by using biotechnology.
  • Types of biologic drugs include vaccines, blood, blood components, cells, allergens, genes, tissues, and recombinant proteins.
  • Biologic products may contain proteins that control the action of other proteins and cellular processes, genes that control production of vital proteins, modified human hormones, or cells that produce substances that suppress or activate components of the immune system.
  • Biologic drugs are sometimes referred to as biologic response modifiers because they change the manner of operation of natural biologic intracellular and cellular actions.

What are biologics used for?

Biologic drugs are used for treatment of numerous diseases and conditions, and are the most advanced therapies available. Some biologic drugs are used for the treatment of Crohn's disease, ulcerative colitis, rheumatoid arthritis, and other autoimmune diseases.

Available biologics have revolutionized cancer treatment, delayed or reversed the course of immune related conditions, changed the lives of people with rare diseases, and have offered hope for many patients who previously had no effective treatment options for their condition.

Examples of medical uses for biologic drugs include:

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What are the side effects of biologics?

Side effects of a biologic drug depends on the specific biologic drug, and method of introduction into the body.

  1. Most biologic drugs have the potential to cause allergic hypersensitivity reactions.
  2. Biologic drugs that are used for rheumatoid arthritis, psoriasis, and other immune related disorders suppress the immune system and increase the risk of infections.
  3. Since some biologic drugs are given by injection they also can cause injection site reactions.
  4. Other biologic drugs are given intravenously and can cause infusion reactions.

These side effects are compiled from side effects listed for several biologic drugs. Each type of biologic drug has its own specific side effect profile and may or may not cause the side effects listed here.

Common side effects of biologic drugs include:

Other side effects of biologic drugs include:

Serious side effects of biologic drugs include:

What preparations are available for biologics?

Biologic drugs are administered by injection or infusion because they are proteins that are quickly digested and inactivated if given by mouth. Therefore, biologic drugs are supplied as powders for infusion or solutions for injection.

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Which drugs interact with biologics?

  • Biologic drugs, for example, adalimubab (Humira), that affect the immune system may interfere with the effectiveness of vaccines. Live vaccines, including attenuated vaccines, should not be used while patients are being treated with biologics that affect the immune system. Patients should complete all recommended immunizations prior to receiving these types of biologic drygs. Prescreening for dormant tuberculosis (TB) generally is recommended.
  • Serious infections are more likely to occur when biologic drugs that suppress the immune system are combined with other drugs that also suppress the immune system.

Are biologics safe to use during pregnancy or while breastfeeding?

  • Most biologic drugs have not been adequately studied in pregnant women or women who are breastfeeding.
  • Some biologics, for example follitropin alpha (Gonal f), nivolumab (Opdivo), and pembrolizumab (Keytruda), may be harmful to the fetus because of their mechanism of action and the results from animal studies.
  • Some biologic drugs may be present in breast milk. Mothers who are breastfeeding should decide with their doctors whether or not to stop or discontinue the biologic because many drugs are excreted in breast milk and there may present a risk of serious adverse effects in the infant.

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What brand and generic names are available for biologics?

List of examples of brand and generic biologic drugs available in the US

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Summary

A biologic drug is a product that is produced from living organisms or contain components of living organisms. Biologics include recombinant proteins, tissues, genes, allergens, cells, blood components, blood, and vaccines. Biologics are used to treat numerous disease and conditions, for example, anemia, chronic migraine, hepatitis B, hemophilia, respiratory syncytial virus (RSV) prophylaxis, HPV prevention, rheumatoid arthritis, inflammatory bowel disease.

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Report Problems to the Food and Drug Administration

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

Medically Reviewed on 7/26/2022
References
FDA. "What is a biological product?" Updated: May 31, 2016.
<http://www.fda.gov/AboutFDA/Transparency/Basics/ucm194516.htm>

FDA. "Complete List of Licensed Products and Establishments." Updated: Oct 31, 2016.
<http://www.fda.gov/BiologicsBloodVaccines/ucm133672.htm>