Sandoz’s Rituxan biosimilar faces setback
Sandoz recently faced a setback in its efforts to get a biosimilar of Roche’s Rituxan (rituximab) to market. The company received a complete response letter from the Food and Drug Administration regarding the biosimilar, meaning it won’t be approving the Sandoz's biosimilar rituximab application in its submitted form.
“Sandoz stands behind the robust body of evidence included in the regulatory submission and is currently evaluating the content of the letter,” the company said. “While disappointed, Sandoz remains committed to further discussions with FDA in order to bring this important medicine to U.S. patients as soon as possible.”
The Novartis company’s biosimilar rituximab was approved in June 2017 by the European Commission, paving the way for its launch. The FDA accepted the application for the U.S. biosimilar in September 2017.
“Sandoz stands behind the robust body of evidence included in the regulatory submission and is currently evaluating the content of the letter,” the company said. “While disappointed, Sandoz remains committed to further discussions with FDA in order to bring this important medicine to U.S. patients as soon as possible.”
The Novartis company’s biosimilar rituximab was approved in June 2017 by the European Commission, paving the way for its launch. The FDA accepted the application for the U.S. biosimilar in September 2017.