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

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advance so that approval will coincide with expiration of a reference product’s exclusivity or patent protection, new draft guidance states; agency targets six-month review of such supplements, rather than the 10 months provided under BsUFA II.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

A new US Food and Drug Administration draft guidance aims to lay out an efficient route by which biosimilar product sponsors can add new or previously protected reference product indications to their labeling.

Biosimilar and interchangeable product sponsors may submit supplemental applications for additional indications in advance so that approval will coincide with...

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