FDA Guides On Adding Biosimilar Indications

Agency Proposes Streamlined Pathway For Biosimilar Indication Carve-Ins

 
• By Sue Sutter
  
Ground level closeup shot of a golf ball set on a wooden golf tee in the grass with a golf club positioned behind it as though about to hit the ball.
Biosimilar sponsors in the US can get supplements for new indications teed up and ready for approval upon expiry of an innovator’s exclusivity or patent protection • Source: Shutterstock

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