FDA Law Blog: Biosimilars

SEPTEMBER 15, 2024

The PREVAIL Act In short, the PREVAIL Act is intended to, among other things, reform the Inter Partes Review (“IPR”) process created by the 2011 Leahy-Smith America Invents Act. Eliminating invalid patents under § 101 enables generic and biosimilar companies to streamline pharmaceutical litigation. beware of Roger “Verbal” Kint.

Biosimilars 76

Biosimilars Drug Pricing 76

Drug Patent Watch

JANUARY 7, 2025

The Importance of Generic Drugs in Healthcare Generic drugs offer several benefits to patients and the healthcare system: Cost-effectiveness: Generic drugs are typically much cheaper than brand-name medications, making treatment more accessible to patients. Food and Drug Administration. ” Health Affairs, 2011.

Communication 89

Communication Dosage Drug Pricing Packaging 89

FDA Law Blog: Biosimilars

DECEMBER 3, 2023

As part of this change, the Coverage Gap Discount Program (CGDP), a program that has existed since 2011, will sunset on December 31, 2024, and be replaced by the Medicare Part D Manufacturer Discount Program (the “Discount Program”). Kirschenbaum — The Inflation Reduction Act (IRA) significantly changed the Part D benefit.

Labelling 105

Labelling Drug Pricing Compounding Payment Processing 105

Safe Biologics

APRIL 25, 2023

By Michael Reilly, Executive Director, Alliance for Safe Biologic Medicines (ASBM) ASBM recently submitted comments to the Centers for Medicare & Medicaid Services (CMS) on the proposed Medicare Drug Price Negotiation Plan. Price controls, as proposed in the negotiation plan, may jeopardize this success.

Drug Pricing 130

Drug Pricing Biosimilars Vaccines 130

Safe Biologics

APRIL 25, 2023

By Michael Reilly, Executive Director, Alliance for Safe Biologic Medicines (ASBM) ASBM recently submitted comments to the Centers for Medicare & Medicaid Services (CMS) on the proposed Medicare Drug Price Negotiation Plan. Price controls, as proposed in the negotiation plan, may jeopardize this success.

Drug Pricing 130

Drug Pricing Biosimilars Vaccines 130