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Evolving Biosimilar Pathway Brings Mid-Review Policy Issues

 
• By Sue Sutter

Drug Review Profile: Labeling, unique fee structure among many challenges that Inflectra sponsor Celltrion and FDA had to navigate in nascent regulatory pathway.

The young age of FDA's biosimilar pathway means there are a host of regulatory, policy and legal issues that FDA and product sponsors are still trying to figure out.

Agency review documents for Celltrion Inc.'s Inflectra (infliximab-dyyb), a biosimilar to Janssen Biotech Inc.'s TNF-inhibitor Remicade (infliximab) and...

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EU Authorization Before US? Biologics Manufacturing Is Likely To Blame

 
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