Follow-On Biologics’ Development Time Requires Picking Brand Winners Early
Developing follow-on biologics will require sponsors to make much better predictions about the future marketplace than are currently necessary for ANDAs, according to Insmed VP-Regulatory Affairs Glen Kelley
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Industry also seems supportive of the idea, while Pew touts the power of the power of track-and-trace as a deterrent.
EMD Serono has been tracking Serostim packages since 2002; J&J is using Prezista 600 mg as a trial run for serialization.
Stakeholder meeting will address poor enrollment rates and other issues that undermine the utility of pregnancy registries, as well as the use of alternatives, such as case control studies and claims-based database studies.