Big Molecule Watch

SEPTEMBER 25, 2023

Last week, FDA released a draft guidance, “ Labeling for Biosimilar and Interchangeable Biosimilar Products ” (“2023 Draft Guidance”) that—when finalized—will revise and replace its July 2018 final guidance, “ Labeling for Biosimilar Products.”

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Labelling Biosimilars Adverse Reactions Dosage 62

PharmaShots

APRIL 6, 2023

A recent study published in the January 2023 issue of Clinical Pharmacology and Therapeutics described essential characteristics of a PD biomarker for biosimilar development.

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Biosimilars Clinical Pharmacology 53

FDA Law Blog: Biosimilars

JULY 17, 2024

In December 2023, FDA established the Genetic Metabolic Diseases Advisory Committee (also called “GeMDAC,” which we blogged about here ) to advise FDA regarding treatments for genetic metabolic diseases (i.e., clinical pharmacology/biomarkers, animal models, real-world evidence and other externally controlled comparisons [e.g.,

Clinical Pharmacology 104

Clinical Pharmacology Drug Development 104

FDA Law Blog: Biosimilars

OCTOBER 28, 2024

To this end, FDA recently announced the publication of a guidance titled “Considerations for Long-Term Clinical Neurodevelopmental Safety Studies in Neonatal Product Development,” (the “Guidance”). This guidance finalizes a draft guidance issued in February 2023.

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Clinical Pharmacology Communication Drug Development 62