Biosimilars Prague 2010

Biosimilars, biobetters and follow-on biologics are the new wave of growth for the pharmaceutical industry. Biosimilar medicines 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 – 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.