Follow-On Biologics Debate Creates Strange Bedfellows As Bills Emerge
Sen. David Vitter's strange bedfellows might help Democrats pick up his seat in 2010, but for now, they are hoping that his unusual alliances will help them advance healthcare reform
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FTC concludes that extended brand exclusivity – or any generic exclusivity – is unnecessary for a robust follow-on biologics market.
Sponsors are committed to firm 12 years of exclusivity, but evergreening remains an obstacle to reintroduction.
The Medicare Payment Advisory Commission is taking up payment issues for follow-on biologics as legislation establishing a regulatory pathway for approving such products gathers momentum in Congress.