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Inflation Reduction Act (IRA) › Biosimilars › Department of Health and Human Services (HHS)

Fish & Richardson

Trump’s Drug Price Executive Order: What Drugmakers Should Know

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On April 15, 2025, President Trump issued an executive order titled “Lowering Drug Prices by Once Again Putting Americans First.” The order reaffirms and seeks to expand on policy initiatives introduced during the president’s...more

Axinn, Veltrop & Harkrider LLP

The Inflation Reduction Act’s First Potential Impact on Biosimilars

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On October 31, 2023, FDA approved Amgen’s Wezlana (ustekinumab-auub) as a biosimilar to and interchangeable with Janssen’s Stelara (ustekinumab). Stelara has been selected by the Center for Medicare & Medicaid Services...more

Mintz - Health Care Viewpoints

Mintz IRA Update — Basics of the Medicare Drug Price Negotiation Program

Mintz - Health Care Viewpoints on

The Inflation Reduction Act (“IRA”) was passed just over a year ago with a goal of lowering high drug costs for Medicare beneficiaries and reducing costs incurred by Medicare. A central piece to achieving the IRA’s goal of...more

Venable LLP

First List of Drugs for Medicare Price Negotiations Published Includes Three Biologics

Venable LLP on

The Inflation Reduction Act (IRA), signed into law on August 16, 2022, allows the federal government to negotiate prices for some high-cost drugs covered under Medicare. ...more

Akin Gump Strauss Hauer & Feld LLP

What a Difference a Year Makes: IRA’s Drug Pricing Provisions Turn One

Akin Gump Strauss Hauer & Feld LLP on

This week marks the one-year anniversary since the enactment of the Inflation Reduction Act (IRA), which included sweeping reforms empowering the Secretary of Health and Human Services (HHS) to set prices for certain...more

Latham & Watkins LLP

Health Care & Life Sciences: Drug Pricing Digest - October 2022 #2

Latham & Watkins LLP on

2022 Medicaid Drug Rebate Program Summit Concludes: The annual Medicaid Drug Rebate Program Summit took place Oct. 12-14 in Chicago. Latham partner Christopher H. Schott spoke at two sessions: the panel “Ask the Attorneys:...more

Goodwin

Recent and Proposed Legislation Affecting Biosimilars

Goodwin on

​​​​​​​Under Section 11403 of The Inflation Reduction Act, effective starting on Monday, October 3, 2022, and for the next five years, Medicare Part B will pay healthcare providers an 8% add-on fee for qualifying biosimilars,...more

Akin Gump Strauss Hauer & Feld LLP

The Impact of the Inflation Reduction Act of 2022 on Pharmaceutical Innovation, Patent Litigation and Market Entry

Akin Gump Strauss Hauer & Feld LLP on

Key Points - The new drug price negotiation process under the IRA takes into account a complex mix of price, competitive status, market exclusivity and scientific data. New price setting provisions built into the IRA...more

Hogan Lovells

Inflation Reduction Act’s Drug Price Negotiation Program explained

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In the first of a three-part webinar series on the recently enacted Inflation Reduction Act of 2022 (IRA), Hogan Lovells partners Alice Valder Curran and Ken Choe discussed the Drug Price Negotiation Program established by...more

ArentFox Schiff

Drug Pricing Reform Finally Becomes Law: What the Inflation Reduction Act Means for Pharma

ArentFox Schiff on

After many years of policy debate and attempts at proposed legislation, some of the most meaningful changes to the ways in which Medicare pays for prescription drugs – and the obligations of manufacturers selling drugs to...more

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