|Event Date/Time: Nov 04, 2010||End Date/Time: Nov 05, 2010|
are already a commercial reality in the European Union. With the passage of the US Health Care Reform legislation in March 2010,
FDA was given authority to approve biosimilars too. Success in the US market, however, will be contingent on the implementation of
the biosimilars approval pathway by the FDA and the submission of quality dossiers that fulfill the new statutory requirements. FDA can approve both biosimilars and interchangeable biosimilars
pathways today â€“ but who will be the first to succeed with the new US pathways and why? Will they be the sponsors of the EU biosimilars with those products, or completely new entrants with
new candidates? Will interchangeability ever be approved by FDA?
Our workshop will discuss strategies to use the new regulatory pathways for biosimilars in EU, US and elsewhere, identify potential priorities for growth and commercial success, consider
ways to overcome development and manufacturing challenges,facilitate the understanding of future trends in biosimilar markets and the consequences for their reference products, and identify efficient market entry strategies. This workshop is relevant to both innovators facing lifecycle management issues for innovator
biologics, and also for those interested in making and licensing biosimilars in the leading highly regulated markets.