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 44

Drug Pricing Biosimilars Dosage Documentation 44

FDA Law Blog: Biosimilars

APRIL 16, 2024

Gaulkin — On April 10, the Fourth Circuit unanimously affirmed a summary judgment ruling for the Centers for Medicare & Medicaid Services (CMS) regarding the agency’s definitions of “line-extension drug” and “new formulation” for purposes of determining rebates that drug manufacturers may owe the Medicaid Drug Rebate Program (MDRP).

Dosage 57

Dosage Drug Pricing Pharmaceutical Manufacturing 57

FDA Law Blog: Biosimilars

SEPTEMBER 23, 2024

There have already been (with more coming) a slew of 40th anniversary celebration papers, analyses, and events in 2024, including: The Brookings Institution’s Hatch-Waxman at 40 The Association for Accessible Medicines’ Hatch-Waxman turns 40. And that name has stuck for many of us. Is it over the hill? (Or

Dosage 57

Dosage Drug Pricing 57

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 57

Biosimilars Drug Pricing Dosage Documentation 57

Big Molecule Watch

JANUARY 19, 2024

As we settle into 2024, we reflect on the significant legal developments of 2023 that hold potential impact on the biologics and biosimilars market. Stay tuned to Big Molecule watch for further developments on these litigations in 2024, including developments on the IPRs related to Regeneron’s patents directed to dosing of aflibercept.

Biosimilars 73

Biosimilars Dosage Drug Pricing 73

FDA Law Blog: Biosimilars

MARCH 5, 2024

By Faraz Siddiqui — Last Friday, the Delaware District Court rejected AstraZeneca’s lawsuit against the Medicare Drug Price Negotiation Program enacted under the Inflation Reduction Act (IRA) and CMS’s guidance implementing it. at least one drug” has been approved and marketed. 16 June 2023) Eliquis Novartis D.N.J. (1

Dosage 62

Dosage Drug Pricing 62

Pharmaceutical Technology

SEPTEMBER 26, 2022

Novartis said in August that it intended to shut down its Sandoz oral solid dosage plant in Wilson, North Carolina, which provides tablets to Canada and the US, next year. Innovative drug development can be costly and risky due to clinical trial attrition of unproven drugs, but can provide a high return on investment when successful.

Biosimilars 64

Biosimilars Drug Development Vaccines Dosage 64