Richter Gedeon Vegyészeti Gyár Nyrt., Farmakológiai és Gyógyszerbiztonsági Kutatási Főosztály
Biopharmaceuticals represent a new class of very effective medications in the management of debilitating and often life-threatening diseases but the costs of these therapies exceed the costs of regular therapies. Biological medicinal products (i.e. smaller proteins or monoclonal antibodies) are mostly complex macromolecules, produced by microbial or mammalian cell cultures in bioreactors through application of complex process technologies. After patent expiry, the production of compounds with comparable quality features and comparable clinical safety and efﬁ cacy proﬁ les become available, however, the complexity of the macromolecules means they are not equivalent in the sense of small molecule generics. Biologics that are similar to a given licensed reference compound and meet regulatory requirements within this context can be termed as biosimilars. The similarity of the two products must be appropriately proven during the products’ marketing-authorisation procedure. As more and more biosimilar compounds have been approved by regulatory authorities in the EU and US it is expected that these products will bring signiﬁ cant healthcare savings and much greater patient access to these revolutionary therapeutics.