FDA Calls for More Data in Pfizer’s Herceptin Biosimilar Application

The FDA sent Pfizer a complete response letter for its proposed biosimilar of Genentech’s Herceptin (trastuzumab), saying it needs to see more data before approving the breast cancer drug.

The CRL is the latest obstacle the company has encountered in seeking biosimilar approvals. Genentech sued Pfizer last November claiming its proposed biosimilar infringed on 40 Genentech patents.

In December, the FDA approved the first U.S. biosimilar for Herceptin, Mylan’s Ogivri (trastuzumab-dkst), giving the product a head start over Pfizer’s drug.