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BIO Statement on SCOTUS Biosimilar Products Ruling

On Monday the United States Supreme Court issued a decision in Sandoz, Inc. v. Amgen, …

WSJ: U.S. Concessions on TPP Means Fewer Cures

Today’s Wall Street Journal editorial, Pacific Trade Brinksmanship, does an outstanding job highlighting the important …

New Report Suggests RDP Does Not Increase Healthcare Expenditures

A new paper by the Geneva Network suggests that increasing the period of regulatory data …

Biosimilars at the Federal Circuit – Can the Parties Be Compelled to Dance?

In 2009, Congress passed the Biologics Price Competition and Innovation Act (“BPCIA”), which for the first …

Updated Legal and Regulatory Frameworks Needed for Biosimilars

Biosimilars raise novel and complex questions of science and law that require updated legal and …

Pitts Sounds off on Biosimilar Naming

This week, the Food and Drug Law Institute published a white paper – Biosimilar Nomenclature: …

Ensuring the Safety and Commercial Success of Biosimilars in the United States

The forthcoming arrival of biosimilars into the U.S has spurred debate over the approaches that …

Delivering the Right Dose, Less Often

Biologics are a growing area of drug development, including life-threatening and life-changing disorders such as …

FDA Week: For Biologics, A Name Isn't Just A Name (Jim Greenwood op-ed)

What is in a name? Names help make medicinal products more easily distinguishable by doctors, …

BIO Responds to GPhA Citizen Petition on Biosimilars Naming

Last September, the Generic Pharmaceutical Association (GPhA) filed a Citizen Petition with the FDA, requesting …