Product-Specific or Class-Specific Biosimilar Guidances? US FDA Wants Feedback

The FDA’s experience with product-specific guidances for generic drugs may impact biosimilar industry decision-making, but the program has improved in recent years.

monoclonal antibdoy — Biosimilar sponsors have 90 days to suggest the type of guidance that would be most helpful from the FDA. • Source: Shutterstock

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 is seeking feedback on whether to focus on development of guidance documents for biologics with no approved...