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Biosimilars: US FDA Asked To Clarify Thinking On Pediatric Studies, Indication Carve-Outs

 
• By Sue Sutter

Draft guidance raises questions about Pediatric Research Equity Act obligations of biosimilar applicants and reference product holders, comments say; industry seeks clarity on review of indications with unexpired exclusivity and requests allowances for situations where a biosimilar's dosage form or labeled conditions of use do not align exactly with those of the reference product.

Arrows miss target

A US FDA draft guidance on biosimilar development has spawned industry questions about pediatric study requirements and renewed calls for a streamlined process for adding protected indications to biosimilar labeling.

In addition, industry commenters seek an FDA declaration that biosimilars may, in some circumstances, be licensed for a route of administration, dosage form, strength or condition of use that

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