Safe Biologics

NOVEMBER 12, 2023

6 would prevent the HHS Secretary from requiring a switching study as part of the data package to receive the interchangeable designation. Pitts: The IRA makes the risks of developing new drugs too high On September 14th, an op-ed by former FDA Associate Commissioner Peter J. However, S.6 ASBM surveys of U.S.

Biosimilars 130

Biosimilars Drug Pricing Packaging Labelling 130

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.

Biosimilars 130

Biosimilars Labelling Drug Pricing Packaging 130

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REMINDER: FDA Draft Guidance Would Remove Interchangeability Statement from Interchangeable Biosimilars Comments Due November 17th On September 15th, the Food and Drug Administration (FDA) released draft guidance removing the interchangeability statement from the product label/package insert.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. However, S.6

Biosimilars 130

Biosimilars Packaging Labelling Drug Development 130