Advertisement

Topics

Biosimilars applications under review by EMA – January 2018

04:52 EST 19 Jan 2018 | Generics and Biosimilars Initiative

The European Medicines Agency (EMA) is the body responsible for approval of biosimilars within the European Union (EU). A legal framework for approving biosimilars was established in 2003. Approval of biosimilars is based on an abbreviated registration process, which allows biosimilars manufacturers to provide a reduced package of information compared to originator drugs, provided they can prove ‘similarity’ to the originator or reference drug.

Original Article: Biosimilars applications under review by EMA – January 2018

NEXT ARTICLE

More From BioPortfolio on "Biosimilars applications under review by EMA – January 2018"

Advertisement
Quick Search
Advertisement
Advertisement