Remove 2003 Remove Biosimilars Remove Drug Pricing
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STAT+: Boehringer Ingelheim layoffs are a sign of dysfunctional Humira biosimilar market

STAT

WASHINGTON —  Boehringer Ingelheim is laying off or relocating its sales staff for its Humira biosimilar Cyltezo in a sign of how difficult it’s been to get drug middlemen to adopt less-expensive versions of the blockbuster, the company confirmed. List prices of Humira biosimilars are as much as 85% lower. 

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The Issue with Reissue: PTE Edition

FDA Law Blog: Biosimilars

Even though the PTE provisions established in the Drug Price Competition and Patent Restoration Act are forty-plus years old, courts are still grappling with questions about how to best implement the Patent Term Extension.

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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

Big Molecule Watch

The Inflation Reduction Act’s Medicare Drug Price Negotiation Program will kick off next week. There are reports that the White House may announce the list of selected drugs even before that deadline, on Tuesday, August 29 th. Before the IRA, the government could not set prices for any drugs covered by Medicare.