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Last week, FDA released a draft guidance, “ Labeling for Biosimilar and Interchangeable Biosimilar Products ” (“2023 Draft Guidance”) that—when finalized—will revise and replace its July 2018 final guidance, “ Labeling for Biosimilar Products.”

Labelling 62

Labelling Biosimilars Adverse Reactions Dosage 62

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.

Biosimilars 86

Biosimilars Dosage Labelling 86

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.

Labelling 104

Labelling Biosimilars Drug Pricing Dosage 104

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; (..)

Drug Pricing 45

Drug Pricing Biosimilars Dosage Documentation 45

Pharma in Brief

JANUARY 25, 2023

Such cases typically concern “skinny labels” in which the generic seeks to avoid reference to indications related to the patented use. Combination use : The FC found that a generic manufacturer’s single-compound product would induce infringement of claims to a combination therapy (see here ).

Biosimilars 52

Biosimilars Dosage Compounding Labelling 52

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.,

Controlled Substances 69

Controlled Substances Chemotherapy Compounding Dosage 69

FDA Law Blog: Biosimilars

MAY 5, 2024

FDA/HHS next reviewed studies investigating safety and efficacy/effectiveness of marijuana, professional societies’ position statements, data from state medical marijuana programs and national surveys, and labeling of relevant FDA-approved products.

Controlled Substances 91

Controlled Substances Chemotherapy Dosage Labelling 91