The US Food and Drug Administration wants industry input on whether product-specific or class-specific guidance would be more useful for accelerating biosimilar development.
Key Takeaways
-
Biosimilars sponsors are asked to give the FDA feedback on whether product-specific or class-specific guidance would be most helpful for speeding development.
-
The agency also wants to know if guidances should focus on biological products with no approved biosmilars and if guidance in areas where there are approved products would be helpful
The agency also is seeking feedback on whether to focus on development of guidance documents for biologics with no approved biosimilars, or continue developing guidances for biosimilar development even after one or more biosimilars have been approved for a product or class, according to a
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?