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

Draft guidance raises questions about Pediatric Research Equity Act obligations of biosimilar applicants and reference product holders, comments say; industry seeks clarity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.