Podcast: Meeting Regulatory Expectations - - BioPharm International

ADVERTISEMENT

Podcast: Meeting Regulatory Expectations


blog comments powered by Disqus


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

ADVERTISEMENT

ADVERTISEMENT

EMA Warns of Falsified Herceptin Vials
April 16, 2014
Mallinckrodt to Acquire Questcor Pharmaceuticals
April 16, 2014
American CryoStem and Rutgers University File Joint Patent on Stem Cell Platform
April 11, 2014
Center for Biologics Evaluation and Research Relocates
April 11, 2014
PhRMA Report Reveals Growth Trajectories and Policy Factors Affecting Biopharmaceutical Growth
April 11, 2014
Author Guidelines

Click here