Biopharmazeutikum und Biosimilar

There is a significant difference between biologics and chemically synthesizable drugs. This is particularly evident in the manufacturing process and especially has implications for regulatory requirements of generic drugs and biosimilars, the off-patent versions of biologics. After a scientific assessment of the aforementioned products, this work addresses the questions of whether the term »biosimilar« is justified in place of »biogenerics«, what practical relevance the local German law has for the approval of biosimilars, and how approval requirements in the EU differ from those in the U.S. In addition, the principle of substitution of biopharmaceuticals in Germany and the U.S. is examined.