STAT

MARCH 18, 2024

The biggest enticement that large pharmacy benefit managers offer to the employers that hire them is drug rebates — a steady stream of money sent back to their clients, a tangible symbol of the discounts that PBMs are able to wrangle out of pharmaceutical companies. Continue to STAT+ to read the full story…

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Biosimilars Drug Pricing Documentation Pharmaceutical Companies 363

Safe Biologics

FEBRUARY 1, 2024

The CHMP recognizes that there may be the potential to waive certain clinical data requirements even for complex biosimilars such as mAbs based on solid evidence of quality comparability.

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Biosimilars Documentation Drug Pricing 130

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.

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Drug Pricing Biosimilars Dosage Documentation 45

Pharmaceutical Technology

SEPTEMBER 15, 2022

YoY growth in revenue during the same period due to its robust pipeline, with Humira topping more than $20bn in sales in 2021, according to GlobalData’s Drugs Database. According to GlobalData’s Drugs Database, Rinvoq and Skyrizi combined are projected to reach global analyst consensus forecast sales of more than $21bn by 2028.

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Vaccines Drug Pricing Biosimilars Documentation 108

Pharma in Brief

JANUARY 10, 2024

Expected highlights for 2024 include a final PTA regime, more details on PMPRB drug pricing guidelines and national pharmacare, and fall-out from the US mass drug importation program targeting Canadian medicines. The employee count cut-off in all small entity definitions has increased from 50 to fewer than 100.

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Drug Pricing Documentation Biosimilars Vaccines 52

Safe Biologics

MAY 10, 2024

Biden Administration HHS Budget Would Permit Third-Party Substitution of All Biosimilars On March 11th, the Biden Administration released its FY25 HHS Budget. and Europe alike, prescribers can already substitute any biosimilar for its reference product. Currently there are 10 biosimilars that can be substituted by U.S.

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Biosimilars Drug Pricing Documentation Labelling 130

Big Molecule Watch

MARCH 1, 2024

Today, the district court for the District of Delaware (Judge Connolly) granted the government’s motion for summary judgment on all claims brought by AstraZeneca in its Complaint challenging the Drug Price Negotiation Program of the IRA. There are now seven remaining lawsuits challenging the Drug Price Negotiation Program of the IRA.

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Biosimilars Drug Pricing Dosage Documentation 57