Biosimilar User Fee Program Stresses FDA/Sponsor Meetings Early And Often
BsUFA agreement negotiated between the agency and industry provides five different types of meetings during the pre-IND and product development stage. FDA will issue a draft guidance on the different types of biosimilar meeting opportunities by 2014.
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Short public meeting on the biosimilar user fee agreement suggests the proof will be in the scheduling.
Agency interactions with sponsors under BsUFA are not dependent upon opening an IND. Sponsors may be able to demonstrate similarity to an FDA-licensed reference product by bridging to foreign clinical data, Associate Director for Biosimilars Leah Christl says.
One project will look at tablet size, odor and other characteristics that in the past have been a source of public complaints about generics.