FDA Law Blog: Biosimilars

SEPTEMBER 19, 2023

The closest FDA has come is in a 2003 preamble noting that patents that claim finished dosage forms—which can include “metered aerosols, capsules, metered sprays, gels, and pre-filled drug delivery systems”—should be listed in the Orange Book, suggesting that a patent that claims both the drug substance and the delivery device should be listed.

Communication 105

Communication Dosage Biosimilars 105

FDA Law Blog: Biosimilars

JUNE 7, 2023

The “façade of ‘negotiations’ and ‘agreements’” require Merck to communicate that it has “agreed” to an HHS-mandated price, and to endorse the viewpoint that the price is ‘fair’”, when in fact there has been neither a real agreement nor a fair price.

Communication 45

Communication 45

pharmaphorum

FEBRUARY 26, 2021

The company has also faced claims that it did not adequately communicate the risks of its opioid painkillers in its marketing, contributing to the US’ ‘opioid epidemic’, and that its talc products could contain small amounts of asbestos and lead to cancer. Litigation & controversy. CEO Alex Gorsky, who was appointed in 2012.

Vaccines 126

Vaccines Biosimilars Labelling Communication 126