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

Lundbeck CEO Resigns Due to Code of Conduct Breach
November 24, 2014
IMS: Global Spending on Medicines to Rise 30% by 2018
November 24, 2014
Janssen Partners with Transposagen Biopharmaceuticals for CAR-T Therapies
November 24, 2014
Amgen Opens Single-Use Manufacturing Plant in Singapore
November 20, 2014
GPhA Issues Statement on Generic Drug Costs
November 20, 2014
Author Guidelines

Click here