Biological medicines (‘biologicals’) contain active substances from a biological source, such as living cells or organisms. The manufacture of biological medicines tends to be more complex than for chemically-derived molecules. Since biosimilars are a type of biological medicine, all features pertinent to biological medicines apply.
Biosimilars are approved according to the same standards of pharmaceutical quality, safety and efficacy that apply to all biological medicines approved in the EU. The aim of biosimilar development is to demonstrate biosimilarity - high similarity in terms of structure, biological activity and efficacy, safety and immunogenicity profile.
Demonstration of biosimilarity relies on comprehensive comparability studies with the reference medicine.