Understanding Recent Changes to 505(b)(2) Drugs and Reimbursement
Pharmacy Times
JUNE 23, 2025
This pathway’s expanded use and shifting Centers for Medicare & Medicaid Services (CMS) policies are reshaping reimbursement practices and therapeutic equivalence standards for 505(b)(2) drugs. It is basically an essential copy, and the pharmaceutical manufacturer has to show bioequivalence to the reference product,” Soefje said. “If
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