DIA Biosimilars 2013

The European Union (EU) was the first jurisdiction to introduce legislation for biosimilars in 2004, followed by the issuance of guidelines by EMA. Today, the EU has multiple biosimilars on the market, some of which go back more than seven years. Also, the EU has developed a detailed framework of guidelines for biosimilars, many of which are currently being revised based on the experience gained. This session will review the evolution of the regulations for biosimilars in the EU and take a look into the future of these regulations. One of the key challenges going forward will be the harmonization of regulations in the US and the EU, so programs do not have to be duplicated. Regulators will share on the progress in the FDA-EMA cluster on biosimilars they have set up. Also, a report on a study conducted by the European Commission (EC) on the biosimilars markets in the various EU countries will be shared. This study analyzed which barriers need to be removed and which incentives need to be put in place to create a fair marketplace for biologics.