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FDA Approves Amgen's WEZLANA As Biosimilar to and Interchangeable With Janssen's STELARA (ustekinumab) - Stelara Is One of the 10 Drugs Selected by CMS for Drug Price Negotiations Under the Inflation Reduction Act

On Tuesday, October 31, FDA approved Amgen’s WEZLANA (ustekinumab-auub) as biosimilar to and interchangeable with Janssen’s STELARA (ustekinumab).  WEZLANA is the first product to be approved as a biosimilar to STELARA.  As we covered previously, Janssen and Amgen settled their BPCIA litigation regarding Amgen’s ustekinumab biosimilar product in May 2023….

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First Drugs Selected for Price Negotiations Under The Inflation Reduction Act To Be Announced Next Week: A Recap of What That Means - The Drug Price Negotiation Program and Pending Legal Challenges

The Inflation Reduction Act’s Medicare Drug Price Negotiation Program will kick off next week.  The statute sets a deadline of September 1, 2023 for the Secretary of Health and Human Services (HHS) to publish a list of the 10 drugs that will be subject to “negotiations” with the government to determine…

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