NORD Slams Orphan Indication Discussion At Biosimilar Advisory Committee
Rare disease group questions FDA's commitment to Orphan Drug Act after agency included a Remicade indication with exclusivity on its Inflectra meeting agenda.
You may also be interested in...
Senate Bill Would Prevent Safety Label Carve-Outs From Delaying Approvals
Updated drug pricing bill would allow US FDA to approve generics even if innovator safety information is protected by exclusivity.
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Draft guidance raises questions about Pediatric Research Equity Act obligations of biosimilar applicants and reference product holders, comments say; industry seeks clarity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.
Celltrion’s Biosimilar Rituximab Brings Indication Carve Outs To US FDA Panel Review
Carve outs highlight growing problem for industry and FDA – the absence of an expedited process for adding or removing biosimilar indications; Celltrion seeks approval for only three of eight indications on label of reference product, Genentech’s Rituxan, due to intellectual property and exclusivity issues.