On January 19, 2023, the FDA Commissioner, Robert M. Califf, delivered remarks at the FDA-USPTO Public Workshop. He noted that, since the issuance of President Biden’s 2021 Executive Order on Promoting Competition, the FDA...more
On October 12, 2022, Amgen released its 2022 Biosimilar Trends Report. Since we posted on Amgen’s report preview in July, the total number of biosimilars that have been approved in the United States has increased from...more
Under Section 11403 of The Inflation Reduction Act, effective starting on Monday, October 3, 2022, and for the next five years, Medicare Part B will pay healthcare providers an 8% add-on fee for qualifying biosimilars,...more
10/13/2022
/ Biosimilars ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Health Care Providers ,
Inflation Reduction Act (IRA) ,
Interchangeability ,
Medicare ,
Medicare Part B ,
Pending Legislation ,
Prescription Drugs
As 2021 comes to a close, Big Molecule Watch reviews the top five biosimilar regulatory developments of the year...
President Biden Signs Orange Book Transparency Act -
In January, we reported that President Biden...more
12/31/2021
/ Biden Administration ,
Biosimilars ,
BPCIA ,
Drug Pricing ,
Executive Orders ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Guidance Update ,
Inter Partes Review (IPR) Proceeding ,
Life Sciences ,
Orange Book ,
Patent Applications ,
Patent Examinations ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Post-Grant Review ,
Prescription Drugs ,
Purple Book ,
Statutory Requirements ,
Transparency ,
USPTO