2026 Biosimilars Drug Pricing 
STAT
SEPTEMBER 6, 2023
29, Medicare released its highly anticipated list of 10 therapies for which it plans to establish a price by 2026. Analysts have rightly criticized the congressional decision to once again confer greater protection on biologics.
STAT
AUGUST 30, 2023
Department of Health and Human Services named 10 medicines that will be subject to price negotiations for the Medicare program in 2026, a milestone and a point to start appraising the impact of the law , STAT explains. Amgen and J&J reached an agreement in May to allow a biosimilar for Stelara no later than Jan.
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Big Molecule Watch
NOVEMBER 6, 2023
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. In that case, according to CMS’s guidance, STELARA would cease to be “selected” on January 1, 2027.
Safe Biologics
OCTOBER 10, 2023
ASBM Statement on Announcement of Medicare Drug Price-Setting List On August 29th, the Centers for Medicare & Medicaid Services (CMS) announced the first 10 drugs selected under its Medicare drug price “negotiation” plan, authorized by the Inflation Reduction Act (IRA) signed into law last year.
Big Molecule Watch
AUGUST 25, 2023
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.
Pharmaceutical Technology
JANUARY 31, 2023
The US omnibus bill passed in late December 2022 will give the agency greater powers to regulate accelerated approval drugs, while the Inflation Reduction Act’s lowering of drug prices will create an uncertain environment for drug developers, he said. That leaves three years for pharma companies to prepare.
FDA Law Blog: Biosimilars
MARCH 5, 2024
By Faraz Siddiqui — Last Friday, the Delaware District Court rejected AstraZeneca’s lawsuit against the Medicare Drug Price Negotiation Program enacted under the Inflation Reduction Act (IRA) and CMS’s guidance implementing it. at least one drug” has been approved and marketed. The court found numerous flaws with this argument.
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