Large Molecule / Compliance Management

FDA Finds No Clinical Differences in Novartis Biosimilar of Amgen Drug

Jan 06, 2015

The Wall Street Journal

The U.S. market may be close to having the first biosimilar available for patients, according to an article in the Wall Street Journal.

FDA staff said there are “no clinically meaningful differences” between Neupogen, an Amgen medicine that is used to prevent infections during chemotherapy, and a biosimilar version from Sandoz. If approved, the Sandoz version would become the first biosimilar in the United States, by way of a regulatory pathway that was created for these medicines three years ago, the article said. The Sandoz drug is already being sold in more than 40 countries outside of the U.S. under the brand name Zarzio. Read the full story