Fierce Pharma November 7, 2023
There might just be a silver lining for Johnson & Johnson in the FDA’s recent approval of Amgen’s Stelara biosimilar. That’s because the coming entry of a cheaper copycat presents J&J with an opportunity to elude Medicare price negotiations outlined in the Inflation Reduction Act (IRA).
Under the price negotiation framework—set to kick off in 2026 for an initial roster of 10 drugs—a therapy could be knocked off the list if a relevant generic or biosimilar enters the market, the Department of Health and Human Services (HHS) said in court documents first posted (PDF) last month. Stelara “proves this point,” HHS argued, noting that the launch of a biosimilar to J&J’s immunology blockbuster was expected “no later” than early 2025.
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