Safe Biologics

NOVEMBER 12, 2023

6 would prevent the HHS Secretary from requiring a switching study as part of the data package to receive the interchangeable designation. Pitts: The IRA makes the risks of developing new drugs too high On September 14th, an op-ed by former FDA Associate Commissioner Peter J. However, S.6 ASBM surveys of U.S.

Biosimilars 130

Biosimilars Drug Pricing Packaging Labelling 130

Safe Biologics

DECEMBER 6, 2023

REMINDER: FDA Draft Guidance Would Remove Interchangeability Statement from Interchangeable Biosimilars Comments Due November 17th On September 15th, the Food and Drug Administration (FDA) released draft guidance removing the interchangeability statement from the product label/package insert. ASBM surveys of U.S. However, S.6

Biosimilars 130

Biosimilars Packaging Labelling Drug Development 130

European Pharmaceutical Review

JUNE 24, 2022

The review was impacted by Brexit and the COVID-19 pandemic, which compounded existing issues surrounding high drug pricing and patient access that had been brewing since 2016 and highlighted several shortcomings in the EU’s pharmaceutical system. pocket expenses account for only seven percent of the overall cost of developing drugs.

Compounding 99

Compounding Drug Development Drug Pricing Dosage 99

European Pharmaceutical Review

DECEMBER 26, 2023

Production cost is currently a fundamental concern for many gene therapy developers, particularly given that some treatments cost millions of dollars per single dose (eg, $3.5 million for Hemgenix [AAV5-hFIX-Padua]).

Drug Pricing 85

Drug Pricing Packaging Vaccines Drug Development 85