The Foundation: What Are Biological Medicines?

Biological medicines, also known as biological therapies or “biologics,” are medicines that are produced by living organisms, including human, animal, or microorganism cells. Proteins, nucleic acids, and living entities such as cells and tissues are examples of biologics. Biologics can either be extracted from natural organisms or produced via recombinant DNA technology (sometimes referred to as “biotechnology”).

Biologics are more complex than traditional, chemically synthesized small molecule medicines in a number of ways, including in their molecular size, three-dimensional structure, inherent variability, stability, and manufacturing processes. Although the first biologics were commonly manufactured by purifying them from animal tissues, since the 1980s many biologics have been produced through recombinant DNA technology, which uses living cells to manufacture proteins and other products of interest in an industrial setting. This has led to increased consistency, yield, and purity.

All biological medicines vary slightly from one batch to the next even when the same manufacturing process is used due to the inherent variability in utilizing a natural process to produce medications. This is normal and expected. The process and product are closely monitored, and strong manufacturing controls are put in place to ensure that all variability stays within pre-specified and pre-approved ranges.

Biologics generally work within a patient’s body by supplementing or interrupting biochemical pathways, processes, and signals in order to treat a specific disease or disorder. Some of the most difficult-to-treat diseases, such as cancer, anemia, and autoimmune disorders (e.g., multiple sclerosis, rheumatoid arthritis, psoriasis, and inflammatory bowel disease) are often treated with biologics. Many biologics are delivered in a health care setting in the form of an injectable or in a solution that is administered intravenously, and some biologics are self-administered at home.

Each new biologic that is approved by the U.S. Food and Drug Administration (FDA) may someday serve as a reference product for a future biosimilar.