Week in Review: Amgen-Horizon Deal Moves Forward, First 10 Drugs for IRA Price Negotiation, Layoffs and More

Pictured: FTC sign on a wall/iStock

Pictured: FTC sign on a wall/iStock

Regulatory actions dominated this week’s news. The Federal Trade Commission on Friday gave clearance to Amgen to proceed with its $27.8 billion acquisition of Horizon Therapeutics. However, it comes with strings. Under a consent order agreement, Amgen is prohibited from bundling any of its products with Horizon’s Tepezza or Krystexxa, which the FTC contends would stifle competition.

Tuesday, the Biden administration announced its list of the first 10 drugs that will be subject to Medicare price negotiations with pharmaceuticals companies. The program, authorized by provisions of the Inflation Reduction Act (IRA), is the beginning of a long and contentious road to generating some $25 billion in drug cost savings for the federal government.

There were no real surprises on Medicare’s initial target list of 10 drugs, which includes drugs to treat diabetes and cancer and collectively cost the U.S. government $50 billion from mid-2022 through mid-2023. Of that amount, about $11 billion was spent on three J&J drugs on the list—Imbruvica (ibrutinib), Stelara (ustekinumab) and Xarelto (rivaroxaban)—more than any other pharma company.

However, Mara Goldstein, managing director of Mizuho Securities, told BioSpace that many of the drugs on the list will “lose exclusivity suggesting minimal commercial impact.” J&J, for example, expects Stelara biosimilars to enter the market in 2025, while the negotiated Medicare process for the initial 10 drugs on the list will take effect in 2026.    

At least eight Humira biosimilars, led by Amgen’s Amjevita which hit the U.S. market in January 2023, are putting pressure on AbbVie. Another potential contender is Alvotech, which has resubmitted its BLA to the FDA seeking an interchangeability designation for its high-concentration biosimilar formulation of AbbVie’s Humira. Alvotech has already been rejected twice by the regulator.

Following the FDA’s recent rejection of zuranolone in major depressive disorder, Sage Therapeutics this week announced a strategic reorganization initiative including laying off 40% of its staff. The layoffs are meant to provide Sage with more resources for commercial hires that will support the launch of zuranolone’s use in a postpartum depression drug under the brand name Zurzuvae.  

Greg Slabodkin is the News Editor at BioSpace. You can reach him at greg.slabodkin@biospace.com. Follow him on LinkedIn.     

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