On August 20, 2024, the Federal Trade Commission (FTC) filed a comment letter in support of the Food and Drug Administration’s (FDA’s) June 2024 draft guidance on biosimilar interchangeability (the “Draft Guidance”). When...more
The U.S. Food and Drug Administration (FDA) recently issued new revised draft guidance on “Labeling for Biosimilar and Interchangeable Biosimilar Products,” which most notably dispenses with any recommendation that...more
On June 25, 2020, the Department of Justice (DOJ) filed a brief in the United States Supreme Court that reverses the government’s prior position by arguing that none of the provisions of the Patient Protection and Affordable...more
7/15/2020
/ Affordable Care Act ,
Biologics ,
Biosimilars ,
Biotechnology ,
BPCIA ,
Constitutional Challenges ,
Department of Justice (DOJ) ,
FDA Approval ,
Food and Drug Administration (FDA) ,
Life Sciences ,
Pharmaceutical Industry ,
Prescription Drugs ,
SCOTUS ,
Severability Doctrine ,
Tax Cuts and Jobs Act ,
Trump Administration
On Friday, FDA published the final guidance, “Considerations in Demonstrating Interchangeability With a Reference Product,” which is intended to assist sponsors in demonstrating that a biosimilar product is interchangeable...more
Yesterday, FDA released a series of guidances that aim to advance the agency’s biosimilars policy framework, along with a proposed rule on the definition of a “biological product,” which incorporates changes made by the...more