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

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,...

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