biologics

Biologics are medical products derived from living organisms or their components. They include large, complex molecules or mixtures produced using biotechnological methods, such as recombinant DNA technology, cell culture, or fermentation. Biologics contrast with small-molecule drugs, which are typically chemically synthesized and smaller in size. The term encompasses a broad range of products, including therapeutic proteins, vaccines, nucleic-acid–based therapies, and cell- or tissue-based products.

Common classes of biologics include monoclonal antibodies, cytokines and growth factors, therapeutic proteins such as insulin or erythropoietin, and vaccines. In addition, newer modalities are increasingly categorized as biologics, such as gene therapies, cell therapies (including CAR-T cells), and tissue-engineered products. Production relies on living systems, often mammalian cell lines or microorganisms, using fermentation or culture processes followed by purification. Because biologics are large and structurally complex, they can vary between production runs, requiring stringent quality control and detailed characterization.

Regulatory oversight for biologics is provided by national and regional agencies, such as the U.S. Food and Drug Administration and the European Medicines Agency. Approval requires extensive nonclinical and clinical testing to establish safety, efficacy, and manufacturing quality. Biosimilars, which are follow-on products to approved biologics, must demonstrate similarity in safety, efficacy, and quality, often through comprehensive comparative studies.

Biologics are used across therapeutic areas including oncology, autoimmune diseases, infectious diseases, and rare genetic disorders. They can pose safety considerations such as immunogenicity, necessitating ongoing pharmacovigilance and post-marketing surveillance. The field faces challenges related to high development costs, complex manufacturing, and supply-chain requirements, while continuing to evolve with advances in platform technologies and precision medicine.