Bookcover of Analysis of the Regulatory Requirements for Biosimilars in the EU
Booktitle:
Analysis of the Regulatory Requirements for Biosimilars in the EU
A General Overview
AV Akademikerverlag
(2016-06-14
)
eligible for voucher
ISBN-13:
978-3-639-88881-2
ISBN-10:
3639888812
EAN:
9783639888812
Book language:
English
Blurb/Shorttext:
A biosimilar is a biological medicinal product which is a copy of an original (innovator) product. The innovator product is often manufactured by a different company and after the patent of the innovator product expires a biosimilar can be registered in the European Union to a lower price than the innovator product. The first biosimilar in the European Union was registered in 2006 and was a Somatropin compound. Now are about 20 biosimilars registered in the European Union. Forecasts expect that there will be a huge amount of biosimilars pushing on the market in the near future and that will have a big influence on the industry.