The bill changes when certain biological drugs may become eligible for Medicare price negotiations if a biosimilar version is being developed. In some cases, the Secretary of Health and Human Services would delay selection for up to two years if information supports that a biosimilar is expected to reach the market within that period. The manufacturer would have to confirm key information in writing under penalty of perjury. Patent litigation would not, by itself, prevent a delay. If a biosimilar is not licensed and marketed within the specified period, the original drug’s manufacturer may have to pay a rebate. The changes would apply to initial price applicability years beginning in 2027.
The bill changes Medicare’s process for selecting certain biological drugs for price negotiations when a biosimilar may soon enter the market. It does not set out direct benefits or requirements for patients.
The bill does not provide a spending estimate. It sets out possible rebates for some manufacturers if a biosimilar is not licensed and marketed within the specified period.
No publicly available information.
No publicly available information.