Biosimilars Forum (07/09/15)

The Biosimilars Forum is taking issue with a proposed CMS rule under which multiple biosimilars to the same reference product would be grouped and issued the same J-code for Medicare reimbursement purposes. "The biosimilars statute, and its legislative history, make clear that each biosimilar product—including multiple biosimilar products associated with the same originally marketed product—should be assigned a unique HCPCS code," said Michael Werner, Biosimilars Forum policy advisor. "This is crucial toward establishing and maintaining a vibrant biosimilars market in the U.S." The forum said the proposal could lead to confusion, and if finalized as written, the policy could lead to reduced investment in biosimilar development. Werner said the Biosimilars Forum plans to respond to the proposed rule by September 8, when the public comment period closes.

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