Topic: Differences in obtaining a marketing authorisation for a biosimilar and the generic form of a small molecule in the EU
Order Description
Describe the differences in obtaining a marketing authorisation for a biosimilar and the generic form of a small molecule in the EU.
In view of the complexity of the regulations for biosimilar products, what are the motivating factors that encourage companies to develop such products?
Word limit 800 to 1200 excluding tables and references.
Use preferably the website sources in the files attached but no limitations of sources…