HHS Secretary Becerra's Statement on the FDA’s Approval of Wezlana
Today, U.S. Department of Health and Human Services (HHS) Secretary Xavier Becerra released the following statement regarding the FDA’s approval of Wezlana (ustekinumab-auub) as a biosimilar to and interchangeable with Stelara (ustekinumab) for multiple inflammatory diseases:
"Americans pay too much for prescription drugs. Lack of affordable access to prescription drugs and other health care services leads to worse health outcomes. That is why the Biden-Harris Administration has made it a top priority to lower health care costs and make sure every American has access to affordable, high quality health care. Increasing competition and the availability of lower cost biosimilars for high-cost prescription drugs is a key part of that effort.
Today’s action by the FDA is a welcome step forward to approve a biosimilar for a drug taken by tens of thousands of Americans. Through President Biden’s Inflation Reduction Act, we were able to remove some of the incentives for drug companies to block biosimilar and generic drugs from entering the market — instead encouraging healthy competition.
The Biden-Harris Administration will continue to support innovation, increased competition, and better market environments so we can reduce drug spending for consumers and throughout the health care system. While today’s action by the FDA is based on the agency's scientific determination regarding safety and efficacy, the availability of additional biosimilar drugs in the market demonstrates how we can realize those goals.
We will not let up in our fight to deliver lower health care costs to more American families."