FDA rejects Pfizer’s Herceptin biosimilar

The US Food and Drug Administration have responded to FDA rejects Pfizer’s Herceptin biosimilar by asking for more technical information, but this does not relate to safety or clinical data contained in the application, the drug giant stressed.

Whilst further information was not disclosed, Pfizer have said it is now working closely with the FDA to address the contents of the letter and “remains committed to bringing this important medicine to patients”.

Herceptin (trastuzumab) currently pulls in nearly $7 billion a year in sales from across its marketed indications in breast and gastric cancer.