FDA Guides On Adding Biosimilar Indications

Agency Proposes Streamlined Pathway For Biosimilar Indication Carve-Ins

 
• By Sue Sutter

Sponsors may submit supplemental applications for additional indications in advance so that approval will coincide with expiration of a reference product’s exclusivity or patent protection, new draft guidance states; agency targets six-month review of such supplements, rather than the 10 months provided under BsUFA II.

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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