Pfenex applauds Sens. Pat Roberts (R-Kan.) and Tom Carper (D-Del.) for their leadership, along with a group of 20 bipartisan U.S. Senators, in urging Acting CMS Administrator Andrew Slavitt to call on the agency to withhold its biosimilar reimbursement policy until the FDA has finalized its regulations regarding biosimilars. As Sens. Roberts and Carper detail in the letter sent yesterday, it is premature for CMS to issue a final rule on the coding and reimbursement of biosimilars before the FDA has released further regulations on biosimilars, most notably on the issues of naming and interchangeability.
The biosimilars market in the U.S. is still in its infancy. It is critical that CMS and FDA to work together to put forward sound policies that support this growing industry, and increase physician and prescriber adoption of biosimilars, ultimately allowing greater patient access to these safe, vitally important therapies. We commend the leadership of this bipartisan group of Senators and urge CMS to act prudently and withhold a final rule on biosimilar reimbursement until there further guidance from the FDA is available.