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.

Biosimilars 53

Biosimilars Clinical Pharmacology 53

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Last week, FDA released a draft guidance, “ Labeling for Biosimilar and Interchangeable Biosimilar Products ” (“2023 Draft Guidance”) that—when finalized—will revise and replace its July 2018 final guidance, “ Labeling for Biosimilar Products.” The fictitious example provided in the 2023 Draft Guidance is “NEXSYMEO.”

Labelling 49

Labelling Biosimilars Adverse Reactions Dosage 49

FDA Law Blog: Biosimilars

JULY 17, 2024

clinical pharmacology/biomarkers, animal models, real-world evidence and other externally controlled comparisons [e.g., In fact, at this Scientific Workshop, Frank called for the creation of an alternative effectiveness standard for ultra rare diseases that relies on all available scientifically valid evidence (e.g.,

Clinical Pharmacology 105

Clinical Pharmacology Drug Development 105

FDA Law Blog: Biosimilars

OCTOBER 28, 2024

The Guidance notes that extrapolation of data across species is challenging; however, in accord with Agency pronouncements elsewhere on this topic, the Guidance describes FDA’s limited experience with alternative assays to characterize neurodevelopmental toxicity while expressing a theoretical openness to such methods when feasible.

Clinical Pharmacology 64

Clinical Pharmacology Communication Drug Development 64

FDA Law Blog: Biosimilars

DECEMBER 6, 2024

The draft guidance includes FAQs covering topics from across disciplines: regulatory review; chemistry, manufacturing, and controls (CMC); nonclinical and pharmacology/toxicology (PT); clinical; and clinical pharmacology.

Documentation 59

Documentation Packaging Clinical Pharmacology Drug Development 59