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FDA Guides On Adding Biosimilar Indications

Agency Proposes Streamlined Pathway For Biosimilar Indication Carve-Ins

Executive Summary

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advance so that approval will coincide with expiration of a reference product’s exclusivity or patent protection, new draft guidance states; agency targets six-month review of such supplements, rather than the 10 months provided under BsUFA II.

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