FDA Law Blog: Biosimilars

MAY 13, 2024

RWD can be collected from a wide range of sources, such as electronic health records, registries, administrative claims, pharmacy data, and feedback from wearables and mobile technology. RWE is “the clinical evidence regarding the usage, and potential benefits or risks, of a medical product derived from analysis of RWD.”

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Agency IQ

FEBRUARY 15, 2024

CDER, CBER 9/30/2027 Revised or final guidance to be released 18 months after the public comment period ends PDUFA Commitment Letter Digital Health Technologies Publish draft guidance describing a process to evaluate a predetermined change control plan for digital health devices. primary and secondary). primary and secondary).

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Agency IQ

OCTOBER 20, 2023

” Interchangeable products can be substituted for the reference product at the pharmacy level, without prescriber intervention, within state and local regulations. By contrast, a biosimilar product is only “highly similar to and has no clinically meaningful differences in terms of safety, purity, and potency.”

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The Pharma Data

NOVEMBER 25, 2020

The most-favored-nation (MFN) model will be in place between January 1, 2021, and December 31, 2027, allowing time for CMS to evaluate its effect on access to therapeutics, their costs, and quality of care. in 2019, according to a report in the American Journal of Health-System Pharmacy. billion in 2019 (up 1.5% billion (up 11.8%

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