Description
It has been estimated that by 2010, approximately one-third of all newly approved drugs will be biologics. In-line with this extraordinary expansion, the market for generic versions of biologics – biosimilars – has also become a huge growth area with patent expiration offering companies fresh opportunities to enter a new and highly profitable market.
With the FDA and EMEA approval of the first biosimilar drug in 2007, biosimilars is now a reality. PTI’s interactive 2-day training course will provide delegates with practical solutions on how to gain regulatory approval through fast, compliant registration applications
