What Are Biologics?

Biological products—biologics—have vastly improved the treatment of conditions such as rheumatoid arthritis, anemia, leukopenia, inflammatory bowel disease, psoriasis, and various forms of cancer. The first biologic (human insulin) was marketed in 1982. Today, biologics are one of the fastest growing segments of the prescription product market.

Biologics are different from the type of conventional medications familiar to most people. Conventional medications (also known as small-molecule drugs) are made from pure chemical substances, and their structure can be identified and characterized relatively easily. They usually are synthesized through a predictable chemical process according to a reproducible “recipe.”

In contrast, biologics are made from material that comes from living organisms, including humans, animals, and microorganisms such as bacteria or yeast. Biological products usually are manufactured using biotechnology methods (e.g., recombinant DNA technology) or other cutting-edge technologies. For example, human insulin was created by growing insulin proteins in a laboratory within Escherichia coli (E coli) bacteria.

Because biologics come from living organisms, they have larger molecules (or mixtures of molecules) and more complex structures than conventional medications. They are not easily identified or characterized, and they cannot be made by following a reproducible recipe. Consequently, the manufacturing process for biologics is far more complicated—and expensive—than it is for conventional medications. Biologics usually cost more than conventional medications; according to one estimate, the average cost for a biologic is 22 times greater than the cost for a conventional medication.