Posted by Michael Wonder on 02 May 2018
Sandoz receives complete response letter from the US FDA for proposed biosimilar rituximab
2 May 2018 - Sandoz, a Novartis division, announced today that the US FDA has issued a complete response letter regarding the biologics licensing application for its proposed biosimilar rituximab.
Sandoz stands behind the robust body of evidence included in the regulatory submission and is currently evaluating the content of the letter.
While disappointed, Sandoz remains committed to further discussions with FDA in order to bring this important medicine to US patients as soon as possible.
