FDA Law Blog: Biosimilars

JUNE 16, 2023

Kirschenbaum — On May 24, Minnesota enacted the Commerce and Consumer Protection Omnibus Bill, Senate File 2744 ( SF 2744 ), which significantly expands the state’s existing drug pricing activities with serious implications for all drug manufacturers, and particularly generic drug manufacturers.

Drug Pricing 45

Drug Pricing Biosimilars Dosage Documentation 45

Big Molecule Watch

MARCH 1, 2024

Today, the district court for the District of Delaware (Judge Connolly) granted the government’s motion for summary judgment on all claims brought by AstraZeneca in its Complaint challenging the Drug Price Negotiation Program of the IRA. There are now seven remaining lawsuits challenging the Drug Price Negotiation Program of the IRA.

Biosimilars 59

Biosimilars Drug Pricing Dosage Documentation 59

Viseven

JANUARY 13, 2023

Defining Drugs Dosage Even when all stages of the clinical trial are over, there are still many things pharmacists and doctors may learn after patients will get access to the new treatment. HEOR Analysis of Patients The social value of the drug in increasing the quality of life is also an important issue.

Pharmaceutical Companies 40

Pharmaceutical Companies Pharmaceutical Companies Dosage Drug Pricing 40

Pharmaceutical Technology

JANUARY 6, 2023

The alleged actions violated the Hatch-Waxman Act, formally known as the “Drug Price Competition and Patent Term Restoration Act of 1984,” which allows generic manufacturers to market their generic versions of previously approved generic medications.

Documentation 97

Documentation Hospitals Dosage Drug Pricing 97