Health Affairs Blog (12/14/15) Wynne, Billy

There are many issues left to be resolved for biosimilars, despite guidance issued after the Food and Drug Administration (FDA) approved the first biosimilar earlier this year. Most importantly, FDA has not yet addressed how it will decide the threshold that biosimilars must meet to be considered "interchangeable." The agency also has not decided on their naming and labeling. FDA policies on biosimilar naming are contested among stakeholders. The Centers for Medicare and Medicaid Services set a reimbursement rate for biosimilars administered under the Medicare Physician Fee Schedule at the drug's average sales price plus an additional 6 percent. All biosimilars for the same reference product also will be grouped under a single payment code, while the reference product will have its own separate code. Some industry stakeholders have criticized this approach, saying it conflicts with FDA's proposal to use distinguishable suffixes for biosimilar naming and could suppress the biosimilars market.

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