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.
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.
More from Market Access
More from Pink Sheet
• By
Newly published insights from a series of European Medicines Agency workshops can guide drug developers in designing development plans that meet the needs of both regulators and health technology assessment bodies.
• By
England’s health technology assessment institute, NICE, is looking to “reimagine” its evaluation process with the help of AI, rather than just using this technology to speed up its existing processes.
• By
Industry lobbing for pharmaceuticals to be exempt from President Trump’s sweeping US tariffs appears to have paid off.