Safe Biologics

NOVEMBER 12, 2023

FDA Draft Guidance Would Remove Interchangeability Statement from Interchangeable Biosimilars- Comments Due November 17th On September 15th, the Food and Drug Administration (FDA) released draft guidance removing the interchangeability statement from the product label/package insert.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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Biosimilars Drug Pricing Packaging Labelling 130

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.

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Drug Pricing Insurance Coverage and Processing Labelling Communication 52

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REMINDER: FDA Draft Guidance Would Remove Interchangeability Statement from Interchangeable Biosimilars Comments Due November 17th On September 15th, the Food and Drug Administration (FDA) released draft guidance removing the interchangeability statement from the product label/package insert.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

Biosimilars 130

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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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Drug Pricing Biosimilars Insurance Coverage and Processing Labelling 40

Big Molecule Watch

JANUARY 10, 2025

Additionally, in October 2024, the FDA approved SELARSDI for a new presentation a single-dose vial for intravenous infusionafter previously approving it for use as a single-dose prefilled syringe for subcutaneous injections.

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Biosimilars Drug Pricing Labelling Communication 45

Proxsys Rx

DECEMBER 11, 2023

However, the level of reimbursement they receive is dependent on the proven efficacy of their drugs — and many of their most expensive specialty drugs are manufactured under what might be labeled as “pseudo-approved” status. Every specialty pharmacy patient you serve should be monitored by a clinic pharmacist.

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Specialty Pharmacies Hospitals Drug Pricing Labelling 52

Proxsys Rx

MARCH 1, 2024

However, the level of reimbursement they receive is dependent on the proven efficacy of their drugs — and many of their most expensive specialty drugs are manufactured under what might be labeled as “pseudo-approved” status. Every specialty pharmacy patient you serve should be monitored by a clinic pharmacist.

Specialty Pharmacies 40

Specialty Pharmacies Hospitals Drug Pricing Labelling 40