Biosimilars Dosage Labelling 
European Pharmaceutical Review
MARCH 6, 2024
The US Food and Drug Administration (FDA) has approved the first and only FDA-approved denosumab biosimilars, to treat all indications of the reference medicines. The FDA noted that its decision for the biosimilars is based on clinical study data, which showed no clinically meaningful differences from the reference medicines.
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Last week, FDA released a draft guidance, “ Labeling for Biosimilar and Interchangeable Biosimilar Products ” (“2023 Draft Guidance”) that—when finalized—will revise and replace its July 2018 final guidance, “ Labeling for Biosimilar Products.”
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FDA Law Blog: Biosimilars
APRIL 2, 2024
In the first category, FDA asks Congress to amend the FDCA to require drug manufacturers to disclose full information about the name and quantity of inactive ingredients in product labeling and permit FDA to disclose to generic sponsors the names and amounts of such inactive ingredients.
FDA Law Blog: Biosimilars
SEPTEMBER 17, 2024
The approved labeling for UBRELVY includes a warning and precaution regarding hypersensitivity reactions, with the most common adverse reactions being nausea and somnolence. Advantage, OPDP. UBRELVY is indicated for the acute treatment of migraine with or without aura in adults and is not indicated for the preventive treatment of migraine.
FDA Law Blog: Biosimilars
JUNE 16, 2023
The Board, in consultation with the advisory council, is tasked with identifying certain prescription drug products based on the following criteria: brand name drugs or biologics for which the WAC increased by more than 15% or more than $2,000 during any 12-month period or course of treatment lasting under 12 months, adjusting for changes in the CPI; (..)
FDA Law Blog: Biosimilars
JANUARY 18, 2024
Thirty-eight states currently authorize marijuana in different dosage formulations for specific qualifying medical conditions. FDA analyzed the following indications: anorexia related to a medical condition, anxiety, epilepsy, inflammatory bowel disease, nausea and vomiting (e.g.,
FDA Law Blog: Biosimilars
MAY 21, 2024
DEA further believes that factual evidence (including scientific data) and expert opinions with additional data on different forms, formulations, delivery methods, dosages, and concentrations “may be relevant.” The eight factors with a summary of relevant findings follow. Basis at 63-64.
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