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

Compounding Pharmacy Issues Recall, But Challenges FDA Decision
July 22, 2014
AbbVie's Acquisition of Shire Could Save $8 Billion in Taxes
July 21, 2014
AstraZeneca Reveals Design for New Global R&D Center and Corporate Headquarters
July 18, 2014
AbbVie to Acquire Shire for $54.7 Billion
July 18, 2014
Particulate Matter Prompts Baxter's Recall of IV Solutions
July 17, 2014
Author Guidelines

Click here