Biosimilars: US FDA Proposes Streamlined Pathway For Indication Carve-Ins

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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