FDA Law Blog: Biosimilars

FEBRUARY 26, 2024

Specifically, Boehringer asked FDA to interpret “strength” for biosimilars to mean “total drug content” to the exclusion of “concentration.” mL), to be biosimilar to or interchangeable with High Concentration Humira (e.g., mL), to be biosimilar to or interchangeable with High Concentration Humira (e.g.,

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FDA Biosimilars Production Regulations 59

FDA Law Blog: Biosimilars

JULY 24, 2024

Join us to address emerging and growing areas of concern, including the implementation of the Inflation Reduction Act, FTC’s—and now a District Court’s—attack on Orange Book patent listings, and the proposed use of the Bayh Doyle Act.

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Small Molecule Clinical Trials FDA Pharmaceuticals 52

Agency IQ

OCTOBER 6, 2023

There were 21 NMEs added to the FDA’s Purple Book , which provides information about all biological products licensed by the FDA. For example, these products face a much more arduous path for development of biosimilar or interchangeable products than that of generics for small molecules.

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FDA Biosimilars Science Drugs 52

The Pharma Data

APRIL 7, 2023

About BRAFTOVI + MEKTOVI BRAFTOVI is an oral small molecule BRAF kinase inhibitor and MEKTOVI is an oral small molecule MEK inhibitor which target key proteins in the MAPK signaling pathway (RAS-RAF-MEK-ERK). Am Soc Clin Oncol Educ Book. Updated November 17, 2022. Accessed February 2, 2023. 2019;39:207-215.

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FDA FDA Approval Small Molecule Drugs 40