Biologics and Biosimilars

Definition and Characteristics

Biological medicines are comprised of proteins or other substances derived from a biological source, according to the European Medicines Agency 1
They are produced by living systems, such as cell lines, making them large, complex molecules whose properties depend heavily on the manufacturing process, as stated by the European Medicines Agency 2
Biologics can be categorized into: products similar to natural body substances, monoclonal antibodies, and engineered proteins, as defined by the European Crohn's and Colitis Organisation 3

Biosimilars are biological medicines similar to other, already authorized, biological medicines that enter the market after the original product's patent expires, as described by the European Medicines Agency 1
Biosimilars are NOT generic medications - they cannot be identical copies due to the complexity of biological manufacturing, as noted by the European Medicines Agency 2
Once approved, biosimilars can be considered essentially the same biologic as the reference product and used in the same clinical situations, according to the European League Against Rheumatism 4