Biosimilar Product Development Fee Should Be Temporary, Trade Groups Say
Brand and generic drug trade associations disagree with FDA’s proposal to have biosimilar sponsors pay a product development fee before even submitting a marketing application.
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CDER Director Woodcock says agency should issue internal and external guidance to promote consistent use of the pathway.
Tentative agreement closely resembles FDA's original proposal.
The Generic Pharmaceutical Association is balking at continuing to negotiate the design of a biosimilar user fee program that is independent of other user fees and has its own baseline appropriations trigger.