2024 Drug Pricing Labelling 
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.
Big Molecule Watch
JANUARY 10, 2025
Here are some of the top regulatory developments from 2024. FDA Approvals in 2024 There were 17 FDA approvals of Biologic License Applications (BLAs), including for Autolus Inc.’s There were also 18 FDA approvals of biosimilar products , including 6 ustekinumab biosimilars and 5 aflibercept biosimilars in 2024 alone.
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Putting Patients First Blog
SEPTEMBER 3, 2024
Overall, while the NHC appreciates CMS’ intent to streamline the data submission process and make it more accessible, we encourage ongoing dialogue and adjustments to ensure that the process remains patient-centered, efficient, and capable of capturing the full spectrum of information necessary to inform meaningful drug price negotiations.
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.
Express Pharma
OCTOBER 2, 2024
Speaking at the recent ASSOCHAM Annual Pharma Summit 2024, Secretary, Department of Pharmaceuticals, Dr Arunish Chawla’s review of the regulatory reforms needs to go hand in hand with the growth opportunities. Companies have also pointed out that QR codes are missing from these batches.
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). It is crucial to consider how off-label uses will be evaluated and incorporated into the negotiation process.
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REMINDER: FDA Draft Guidance Would Remove Interchangeability Statement from Interchangeable Biosimilars Comments Due November 17th On September 15th, the Food and Drug Administration (FDA) released draft guidance removing the interchangeability statement from the product label/package insert.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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