Clinical Requirements for the Development of Biosimilar Products
Dr. Katja Schepper, Kohne Pharma GmbH, Haan (Germany)
Korrespondenz: Dr. Katja Schepper, Kohne Pharma GmbH, Schallbruch 1, 42781 Haan (Germany),
“Biosimilars” are biological medicines with the same active substances as biotechnology products already approved in the EU. A range of biosimilar products from different companies have meanwhile been approved by the European Commission and thus have jump-started competition for these products. Contrary to the US, the European Union developed a “biosimilar” regulatory framework providing general and product-specific development guidance. Whether these products will be able to substantially reduce the treatment costs for these medicines will have to be proven.