biologika

Biologika, or biologics, are medical products derived from living organisms or their cells through biotechnological methods. They include monoclonal antibodies, recombinant proteins such as hormones and enzymes, vaccines, and more recently gene- and cell-based therapies. Biologics are typically large, complex molecules or living cells, and differ from traditional small-molecule drugs in origin, structure, and manufacturing. Their therapeutic effects are often highly specific and tightly regulated.

Manufacturing and quality: Biologics are produced in living systems, such as bacteria, yeast, or mammalian cell lines, using complex bioprocesses. Because they are sensitive to manufacturing conditions, they require strict quality control and characterization. Products are regulated under good manufacturing practice (GMP) and undergo extensive testing for safety and efficacy.

Regulatory landscape: In the United States, biologics are approved via a biological license application (BLA) submitted to the FDA. In the European Union, marketing authorizations are issued by the European Medicines Agency (EMA) under centralized or national procedures. Biosimilars—sufficiently similar to an approved originator—follow dedicated pathways and require studies to demonstrate similarity in structure, function, and clinical performance.

Applications: Biological medicines are used to treat cancer, autoimmune diseases, vaccines, and rare genetic disorders. Notable categories include monoclonal antibodies used for targeted therapy, recombinant insulin and enzymes for enzyme replacement, and vaccines that prevent infectious diseases.

History and impact: Biologics emerged with recombinant DNA technology in the 1980s, yielding the first approved products and transforming many treatment options. Their high development costs and complex manufacturing have shaped regulatory policy, pricing, and access discussions.