Approval: In the U.S., a government agency called the Food and Drug Administration, or FDA, decides if a medicine should be made available based on strict clinical trial requirements. If the decision is yes, that is approval, and the medicine is called an approved medicine.
Biosimilar: A medicine developed and proven to be highly similar to an existing biologic. Biosimilars are expected to have no differences from the original biologic in how well they work and how safe they are. Read the full list of all FDA-approved biosimilars.
Biologic: A type of medicine made using complex processes in living organisms, instead of chemistry. A biologic differs from other medicines in the way that it is made.
Clinical trials: Studies in people.
Efficacy: How well a medicine works.
FDA: U.S. Food and Drug Administration. This is the government body that decides if medicines should be made available to patients based on how safe they are, how well they work, and what the side effects are.
Flare: A term used when a disease has gotten better but then suddenly gets worse.
Generics: A less expensive option for drugs that are made by chemistry. Generics are an exact replica of the medicine they copy. Because of how biologics are made (complex manufacturing using living organisms instead of chemistry), exact copies (generics) aren’t possible.
Inflammatory bowel disease (IBD): A disease where there is inflammation, or swelling, in the gastrointestinal (GI) tract and a life-long immune response. IBD causes the body and immune system to think that food, bacteria and other needed things in the intestines are not supposed to be there. The body attacks the cells of the intestines, causing inflammation that does not easily go away. The two main types of IBD are ulcerative colitis and Crohn’s disease.
Integrin-receptor antagonists: A type of biologic used to treat inflammatory bowel disease (IBD) by blocking a protein on the surface of cells and preventing it from moving out of the blood vessels and into tissues. An example is vedolizumab (brand name: Entyvio®). Biosimilars are not yet available for this kind of biologic.
Interleukin-12/-23 (IL-12/-23) antagonists: A type of biologic medicine that blocks two cytokines (chemicals made by cells that affect other cells, specifically IL-12 and IL-23) from causing swelling in Crohn’s disease and other autoimmune diseases. An example is ustekinumab (brand name: Stelara®). Biosimilars are not yet available for this kind of biologic.
Interchangeability: Some biosimilars may be called “interchangeable” after they pass through extra testing in clinical trials. Interchangeable biosimilars are not yet available for any biologics. All approved biosimilars, whether or not they are designated interchangeable, meet the FDA’s high standards.
Intravenous infusion: A way many biologic drugs (including biosimilars) are given. A needle is placed in the patient’s vein and the medicine is delivered into the vein over a period of time. This is often done in a special medical office called an infusion center.
Immunogenicity: Refers to a person’s immune system “rejecting” a medicine.
Nocebo: A term used when unwanted effects of a medicine are thought to be caused by a person’s thoughts about the medicine and not the medicine itself. For example, if a person thinks they will experience a specific side effect of a treatment, they might experience the symptoms because of those thoughts.
Originator biologic: The original (first) biologic of its type approved by the FDA. Biosimilars copy the original biologic after it loses its exclusive patent. Also called originator product, or reference biologic, or biologic product.
Payor: The organization paying for a medicine. For example, insurance companies and Medicare are payors.
Pharmacokinetics: What happens to a medicine once it’s put into the body in terms of the amount available and amount of time it remains available. Pharmacokinetic studies are done with biosimilars to make sure the original biologic and biosimilar are treated the same by the body.
Side effects: Undesirable things that may happen with a medicine. Studies of biosimilars look at side effects to make sure no meaningful differences are seen with the original biologic vs the biosimilar.
Tumor necrosis factor (TNF) antagonists: A type of biologic that binds to and blocks a small protein called TNF-α, which is linked to swelling in the intestine and other organs and tissues. TNF antagonists (also known as TNF inhibitors) lessen the symptoms of IBD and help healing of an inflamed intestine. Biosimilars are available for this kind of biologic. Examples include:
This activity was supported by an independent educational grant from Pfizer.