FDA Law Blog: Biosimilars

JUNE 16, 2023

Kirschenbaum — On May 24, Minnesota enacted the Commerce and Consumer Protection Omnibus Bill, Senate File 2744 ( SF 2744 ), which significantly expands the state’s existing drug pricing activities with serious implications for all drug manufacturers, and particularly generic drug manufacturers.

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Safe Biologics

DECEMBER 3, 2023

The most recen t of the webinars, hosted July 29th, examined the negative impact of the Inflation Reducation Act’s Medicare drug price setting provisions. The guidance removed the interchangeability statement from the product label/package insert of interchangeable biosimilars.

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Big Molecule Watch

JANUARY 25, 2024

As we kick off 2024, we reflect on regulatory developments in the biologics and biosimilars space in 2023. The licensure and marketing of WEZLANA could affect negotiations with CMS regarding Medicare pricing for STELARA under the Inflation Reduction Act’s Drug Price Negotiation Program.

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Safe Biologics

DECEMBER 6, 2023

REMINDER: FDA Draft Guidance Would Remove Interchangeability Statement from Interchangeable Biosimilars Comments Due November 17th On September 15th, the Food and Drug Administration (FDA) released draft guidance removing the interchangeability statement from the product label/package insert. ASBM surveys of U.S.

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Safe Biologics

MAY 10, 2024

View ASBM’s educational fact sheet “Interchangeability: US vs EU” here. Biden’s SOTU: 500 Drugs To Be Subject to Medicare Drug Price Controls On March 7th, President Biden gave his State of the Union address to Congress, wherein he laid out upcoming policy priorities for a potential second term.

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FDA Law Blog: Biosimilars

DECEMBER 3, 2023

As part of this change, the Coverage Gap Discount Program (CGDP), a program that has existed since 2011, will sunset on December 31, 2024, and be replaced by the Medicare Part D Manufacturer Discount Program (the “Discount Program”). Manufacturers must sign the agreement by March 1, 2024, to participate in the 2025 plan year.

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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.

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