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.

Biosimilars 130

Biosimilars Labelling Drug Pricing Packaging 130

Safe Biologics

NOVEMBER 12, 2023

View the full webinar here or watch individual segments linked below. 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. Thanks to the IRA’s price controls, medical marvels like Keytruda will now be even more difficult to achieve.

Biosimilars 130

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REMINDER: FDA Draft Guidance Would Remove Interchangeability Statement from Interchangeable Biosimilars Comments Due November 17th On September 15th, the Food and Drug Administration (FDA) released draft guidance removing the interchangeability statement from the product label/package insert.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

Biosimilars 130

Biosimilars Packaging Labelling Drug Development 130

Putting Patients First Blog

JULY 2, 2024

General Comments The NHC appreciates CMS’ commitment to actively engaging with stakeholders, including patients, consumer advocates, and health experts, in implementing the Medicare Drug Price Negotiation Program (DPNP). Finally, we encourage CMS to consider a longer time horizon for the submission of data.

Drug Pricing 52

Drug Pricing Insurance Coverage and Processing HIPAA Labelling 52

Big Molecule Watch

AUGUST 25, 2023

The Inflation Reduction Act’s Medicare Drug Price Negotiation Program will kick off next week. In anticipation of this announcement, below is a recap of the IRA’s Drug Price Negotiation Program and pending legal challenges to various aspects of the program.

Drug Pricing 40

Drug Pricing Biosimilars Insurance Coverage and Processing Labelling 40

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.

Biosimilars 130

Biosimilars Drug Pricing Documentation Labelling 130

Safe Biologics

APRIL 10, 2023

CMS Releases Guidance Memo on Medicare Drug Price Negotiation; Allows Only 30 Days to Comment On March 15, 2023, the Centers for Medicare and Medicaid (CMS) released an initial Guidance Memo regarding implementation of its Medicare Drug Price Negotiation Program, authorized by the Inflation Reduction Act (IRA) signed into law August 16, 2022.

Biosimilars 130

Biosimilars Drug Pricing Diabetes Labelling 130