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

NIH Seeks to Improve Vaccine Response with New Adjuvants
September 30, 2014
Baxter International Plans to Open R&D Center for Baxalta
September 30, 2014
FDA Releases First-Ever Purple Book for Biosimilar Characterization
September 26, 2014
FDA and NIH Win Award for IP Licensing of Meningitis Vaccine
September 26, 2014
FDA Releases REMS Report
September 25, 2014
Author Guidelines

Click here