Biosimilar User Fee Negotiations Under Way; Timetable Compressed
FDA has started biosimilar user fee negotiations with industry, although it does not appear the room is overcrowded with participants.
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FDA asks negotiators from the four industry groups to coordinate proposed changes as BsUFA renewal talks get underway.
Group of 11 companies is focusing on biosimilar reimbursement and educational issues important to market formation.
Tentative agreement closely resembles FDA's original proposal.