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Medicare Director: ‘Bona-Fide’ Generic Marketing Likely Product-Specific For IRA

 
• By Sarah Karlin-Smith

CMS won’t put a number on ‘bona fide” generic and biosimilar competition. Medicare's head also discussed how it will ensure rebates don’t disadvantage drugs with government-negotiated prices.

Protect Our Care: Lowering Drug Costs
Medicare's chief answered questions about the newly finalized IRA guidance 10 July • Source: Pink Sheet

Medicare is unlikely to land on a single numerical threshold for what qualifies as “bona-fide” marketing of generic or biosimilar competition to a brand drug when determining whether a brand medication qualifies for negotiation under the Inflation Reduction Act.

“I think every drug is different, right,” Meena Seshamani, US Centers for Medicare and Medicaid Services deputy administrator and director, said 10 July at a Protect Our Care roundtable on lower drug prices. She was asked for her thoughts on a suggestion in a recent

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UroGen’s Mitomycin: Are Randomized Trials For Bladder Cancer Necessary?

 
• By Sue Sutter

The Oncologic Drugs Advisory Committee will vote on the risk-benefit of UGN-102 for low-grade, intermediate-risk, non-muscle invasive bladder cancer based on data from a single-arm trial, but the FDA also seeks input on requiring randomized studies for future treatments.

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