U.S. cites Stelara biosimilar approval in PhRMA IRA case

ARTICLE | Politics, Policy & Law

Justice Dept. says biosimilar will cause deselection before IRA hits Part B prices

By Steve Usdin, Washington Editor

November 3, 2023 9:41 PM UTC

The U.S. Department of Justice is arguing that approval of Amgen’s Wezlana ustekinumab, a biosimilar version of Johnson & Johnson’s Stelara, undermines PhRMA’s lawsuit that seeks to overturn the IRA’s Medicare drug negotiation program.

PhRMA’s partner in the litigation, the National Infusion Center Association (NICA), has argued that it has standing in the case because the IRA will cause reductions in its members’ reimbursement for infusing Stelara ustekinumab. Medicare Part B coverage includes add-on payments for infusion clinics that are based on a percentage of a drug’s price.