In the EU, rare diseases that are also life-threatening or chronically debilitating with a low prevalence and a high level of complexity are defined as orphan diseases.
Manufacturing biological medicines is generally more complex than the production of traditional (
The biotech industry proposes the development of shared European standards for HTAs to ensure the
Innovative medicines generally benefit from a certain period of intellectual property protection
Biosimilar medicines are follow-on versions of original biological medicines.