Podcast: Meeting Regulatory Expectations

Dec 05, 2011
By BioPharm International Editors


In this second of three podcasts, Anjan Selz, cofounder and CEO of Finox Biotech, a company focused on bringing biosimilars to market, discusses his interactions with EMA and FDA and proffers that preparation and early communication are key to avoiding potential hurdles. Selz also dispels some myths; the authorities, particularly FDA, often reacted positively to negotiation and being told “no!” Selz says that the shared goals of ensuring that safe but affordable products reach patients drove discussion forward. Selz also tackles the big question of “how similar is similar?” and how going “one step further” really builds credibility down the line. Posted Jan. 2012.

Podcast 1 on biosimilar candidate choice and outsourcing