biologic

Biologic, or biologics, is a term for any product derived from living organisms or containing components of biological origin that is used to diagnose, prevent, or treat disease. The term is often used to distinguish these products from traditional small-molecule drugs. Biologics include vaccines, blood components, tissues, and cellular, gene, and antibody therapies, such as monoclonal antibodies and recombinant proteins.

Biologics are typically produced using living systems such as bacteria, yeast, mammalian cell cultures, or viral vectors, through complex biotechnological processes. They tend to be large, structurally intricate molecules or heterogeneous mixtures, which can lead to batch variability and require extensive quality control and analytical characterization. They often demand careful storage and a reliable cold chain.

Regulatory frameworks treat biologics as a distinct class from chemically synthesized medicines. In the United States, they are regulated by the FDA’s Center for Biologics Evaluation and Research and approved through a Biologics License Application. In the European Union, marketing authorization is overseen by the European Medicines Agency, with biosimilars—products highly similar to an approved reference biologic—subject to specific comparability requirements due to inherent complexity.

Safety and efficacy can be influenced by manufacturing changes, necessitating stringent good manufacturing practice and post-market surveillance. Immunogenicity and other class-specific adverse events are monitored as part of ongoing safety programs.

History and scope: biologics emerged from serum therapies and evolved with recombinant DNA technology, enabling monoclonal antibodies and advances in cell and gene therapies. Today, they are central to treatments in oncology, autoimmune disease, and genetic disorders, with ongoing research expanding their applications.