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Foundations

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, antibodies, vaccines, gene therapies, and plasma treatments 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 often manufactured by purifying them from animal tissues, since the 1980s many biologics are now produced through recombinant DNA technology, which allows living cells to manufacture proteins and other products of interest in an industrial setting. This has led to increased consistency, yield, and purity.

Biologics are more complex than traditional, chemically synthesized, small-molecule medicines.

Biologics generally work within a patient’s body by supplementing, interrupting, or directing natural 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 best treated with biologics. Many biologics are delivered in a health care setting in the form of an injectable or in a solution to be administered intravenously, and some are self-administered at home. Most biological medicines must be stored at low temperatures.

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