Today, drugs are not only produced in chemistry laboratories, but also with the help of living cells, i.e. biotechnologically – so-called biopharmaceuticals. Animal cells, yeast or bacterial cultures, and – very rarely – plant cells are used.
In contrast to chemical synthesis, biotechnology can also be used to produce highly complex active ingredients (such as insulin, beta interferon) and treat diseases that were previously impossible or difficult to treat. However, the production process for biopharmaceuticals is not only more expensive, but also much more complex and time-consuming than for active ingredients that originate from the chemistry laboratory – chemical synthesis is only suitable for active ingredients with a simpler chemical structure.
Biopharmaceuticals represent one of the fastest growing subsectors of the pharmaceutical market. More than 140 biopharmaceuticals are currently approved in Germany. They are based on 108 genetically engineered active ingredients. Work is underway on numerous other biopharmaceuticals.
Biosimilars: Imitation biopharmaceuticals
The original cell line is only available to the original manufacturer. Other pharmaceutical companies may use a related cell line, but this will never be identical to that of the original manufacturer. Even the smallest deviations in the manufacturing process, however, can significantly affect the efficacy and safety of the drug. Unlike generics, biosimilars must therefore prove both properties in elaborate studies on cell cultures, animals and humans.
There are currently 14 biosimilars approved in Europe. These include preparations for anemia, the blood formation disorder neutropenia, and short stature.
