Biologic products, or biologics, are medical products made from living sources such as humans, animals, or microorganisms, rather than being chemically synthesized like most conventional drugs. The U.S. Food and Drug Administration lists vaccines, blood and blood components, allergenics, somatic cells, gene therapies, tissues, and recombinant therapeutic proteins as examples. They can be made of sugars, proteins, nucleic acids, or combinations of these, and some are living cells or tissues.
Unlike a typical small-molecule drug whose chemical structure is fully known, most biologics are complex mixtures that are hard to fully identify or characterize. They also tend to be sensitive to heat and vulnerable to microbial contamination, so they must be manufactured under aseptic conditions from the earliest steps. In the United States, biologics are regulated by the FDA, largely through its Center for Biologics Evaluation and Research.
Source: U.S. FDA: What Are “Biologics” Questions and Answers
Image: Vaccine vials at Bio Farma in Bandung, Indonesia, by Ümit Kartoğlu for VOA, public domain, via Wikimedia Commons.