Biologics and biosimilars
Biologics are medicines that are made using biological substances. For example, they may contain cell parts, proteins or genetically engineered organisms. Biological medicines have a much more complex structure than chemical medicines do.
The hormone insulin was one of the first biologics to be developed. Since the 1980s, human insulin has been produced with the help of living organisms. There are now about 300 approved biologics in Germany alone. In addition to hormones such as insulin, these include vaccines, antibodies, anti-inflammatory drugs and blood products like coagulation factors (clotting factors). Biologics play an important role in the treatment of autoimmune diseases such as rheumatoid arthritis, as well as in the treatment of cancer.
The production of medicines made from biological substances must be more closely monitored than that of chemical medicines because there may be natural fluctuations. So each new production unit (batch) of biologics must be proven to be just as effective as the one that was originally approved. This means that manufacturers of biologics must test samples of each new batch to find out whether they are effective.