WASHINGTON, DC - The Subcommittee on Health, chaired by Rep. Joseph Pitts (R-PA), today held a legislative hearing entitled, “Examining Implementation of the Biologics Price Competition and Innovation Act." The hearing provided an opportunity to get an update on the regulation and approval of biosimilars from the Food and Drug Administration (FDA) as well as an update on the reimbursement policy recently outlined by the Centers for Medicare and Medicaid Services (CMS).
The subcommittee explored the various ways that differentiate biosimilars and their regulation. Members raised concerns that these unique qualities were not properly considered by CMS, and that the existing payment policy could negatively impact future biosimilars entering the market or ultimately limit beneficiary access and program savings.
Building on these concerns, when Chairman Emeritus Joe Barton (R-TX) asked Sean Cavanaugh, Deputy Administrator and Director of CMS’ Center of Medicare, if the agency has plans to revisit how these drugs are priced, Cavanaugh remarked that they will be monitoring the market closely and rulemaking could be possible in the future (watch here ).
Enacted in 2010, the Biologics Price Competition and Innovation Act established a new, abbreviated approval pathway at the FDA for biological products determined to be “biosimilar" to or “interchangeable" with a previously FDA-licensed product. In 2012, the first Biosimilar User Fee Act was enacted to support FDA’s work related to the development, review, and approval of these products. FDA has issued several guidance documents on certain key policy considerations, and in March 2015 the agency approved the first biosimilar. In preparation for biosimilars entering the market, CMS published final rules setting the stage for how the Medicare program will reimburse for biosimilar products.
