Alters when biosimilar biological products are eligible for price negotiations under the Medicare program.
The bill amends title XI of the Social Security Act to change the eligibility criteria for biosimilar biological products to participate in Medicare price negotiations. It specifies that a biosimilar biological product will not be eligible for price negotiations if the Secretary determines there is a high likelihood that the product will be marketed within a specified time period. The bill also includes provisions for automatic delays in negotiations if certain conditions are met, such as ongoing clinical studies or the absence of necessary studies.
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