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

 
• By Sarah Karlin-Smith

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

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