Amgen’s Wezlana Adds Legal Obstacles to Drug Pricing Battle

The FDA’s approval of Wezlana as an interchangeable biosimilar to inflammatory disease drug Stelara underscores the legal obstacles the pharmaceutical industry faces in lawsuits seeking to block implementation of the Medicare drug price negotiation program.

The Centers for Medicare & Medicaid Services was specific in its selection of the first 10 drugs up for price cuts under the program launched by last year’s Inflation Reduction Act. The agency selected products with the highest total Medicare Part D gross coverage with no generic or biosimilar competition.

That made the selection of Johnson & Johnson’s Stelara a surprise, since a biosimilar was ...