Biogenerics are Medicines of biological origin, i.e. non-synthetic that contains the same active substance as another one already sold on the market. Biogenerics are also known as Biosimilars or Follow-on biologics. Besides the super mergers and acquisitions taking place within the pharma biotech sphere, many biogenerics and biosimilars are expected to enter the market in the next years.
Biogenerics are subject to an approval process which requires substantial additional data to that required for chemical generics, although not as comprehensive as for the original biotech medicine. However, the safe application of biologics is also dependent on an informed and appropriate use by healthcare professionals and patients. Introduction of biogenerics also requires a specifically designed pharmacovigilance plan.