Future FDA Biosimilars Regulation: Challenges and Possible Solutions

Posted 13 November 2013 By Padmini Sahoo

"The future regulation of biosimilars in the US should be aimed at significantly reducing development costs and regulatory hurdles," argues Padmini Sahoo in this feature article for Focus. Sahoo provides an overview of biosimilars in the US, including the law that created them and a comparison between US, EU and global approaches toward regulation.

Share this article:

Categories: Features, US, FDA

Tags: Biosimilars Regulation, BPCI Act, Biosimilarity, Biosimilars

Regulatory Exchange: Latest Updates From the Community