How does the FDA define "biologics"?

The FDA defines biologics as products that are derived from living organisms and are used for diagnosis, prevention, or treatment of diseases. This definition encompasses a wide range of products including vaccines, blood and blood components, allergenic products, somatic cells, gene therapies, and tissue products. The emphasis on derivation from living organisms highlights the biological nature of these products, marking a distinct difference from chemically synthesized drugs.

Biologics can be complex and are often produced using biotechnology, making them unique in how they interact with biological systems. This definition underlines the FDA's recognition of the importance of biologics in modern healthcare, serving therapeutic purposes that may not be achievable with traditional chemical drugs.

The other answer options do not align with the FDA’s definition. For example, products made solely from chemicals do not qualify as biologics, which inherently require biological origins. Restricting the definition to only vaccines and blood products ignores the breadth of biologics, which includes a variety of therapeutic modalities beyond just these two categories. Lastly, artificially manufactured drugs refer to synthetic pharmaceuticals, again not fitting within the biologic classification established by the FDA.