Safe Biologics

NOVEMBER 12, 2023

View the full webinar here or watch individual segments linked below. 6 would prevent the HHS Secretary from requiring a switching study as part of the data package to receive the interchangeable designation. Thanks to the IRA’s price controls, medical marvels like Keytruda will now be even more difficult to achieve. However, S.6

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Safe Biologics

DECEMBER 3, 2023

ASBM and GaBI Webinar Examines Policy Challenges to Interchangeable Biosimilars On November 30, ASBM and the Generics and Biosimilars Initiative (GaBI) hosted I nterchangeable Designation for Biosimilars- Ensuring Continuity of Patient Care: Upholding Interchangeability Status for Biosimilars. Learn more about ACR Convergence 2023 here.

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REMINDER: FDA Draft Guidance Would Remove Interchangeability Statement from Interchangeable Biosimilars Comments Due November 17th On September 15th, the Food and Drug Administration (FDA) released draft guidance removing the interchangeability statement from the product label/package insert.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

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Putting Patients First Blog

DECEMBER 13, 2023

In response, a debt ceiling package was signed without Medicaid work requirements, symbolizing the power of patient advocates’ voices. In submitted comments , the NHC commended CMS for its initiatives to reduce patient burdens, while also emphasizing the importance of continued monitoring and oversight to strengthen the program.

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