FDA responds to CMS biosimilars proposal

FDA is working with CMS on a pharmacovigilance plan that would accommodate the Medicare agency's plan to assign the same reimbursement code to all biosimilar versions of a reference product.

CMS has proposed that all biosimilars for a given reference product covered under Medicare Part B be issued the same Healthcare Common Procedure Coding System (HCPCS) code. The proposal is designed to ensure that all biosimilars are reimbursed at the same rate (see BioCentury Extra, July 10). ...