Medicinal products obtained from living cells in complex biotechnological processes nowadays play a central role in the therapy and diagnosis of diseases such as cancer and diabetes.
Interferons, monoclonal antibodies, coagulation factors, and insulin and other hormones are examples of these products, which are known collectively as biologicals. In contrast to standard chemical products, these medicines consist of several highly complex large molecules and can be extremely sensitive to changes (for example of temperature or the composition of the nutrient medium) during their manufacture. The manufacture of biologicals is a technically demanding and intricate operation.
For some years now, Switzerland has also been authorising biosimilars – imitations of the original biologicals – once the patent on the original product has expired. Unlike copies of chemical medicines (generics), biosimilars are never entirely identical to the original active substance but only similar to the original, hence the name biosimilar. Biosimilars are not generics. The procedure used to authorise them is therefore more complex and requires more surveillance measures than for standard generics.