The US FDA's upcoming plans to stimulate and streamline biosimilar development could include the ability for sponsors to use European-approved reference products to gain US approval.
Commissioner Scott Gottlieb said the issue is one of the items that could appear in the biosimilar innovation plan, which he said could be announced Thursday
Read the full article – start your free trial today!
Join thousands of industry professionals who rely on Pink Sheet for daily insights
- Start your 7-day free trial
- Explore trusted news, analysis, and insights
- Access comprehensive global coverage
- Enjoy instant access – no credit card required
Already a subscriber?