Posted by Michael Wonder on 23 Apr 2018
Pfizer provides update on proposed trastuzumab biosimilar
23 April 2018 - Pfizer today announced that it received a complete response letter from the United States FDA in response to the biologics license application for the company’s proposed trastuzumab biosimilar.
In the letter, the FDA highlighted the need for additional technical information. The additional requested information does not relate to safety or clinical data submitted in the application.
Pfizer is working closely with the FDA to address the contents of the letter and remains committed to bringing this important medicine to patients in the U.S.
