FDA Approves Pfizer's Trastuzumab Biosimilar, Trazimera

The FDA has approved Pfizer’s trastuzumab-qyyp (Trazimera), a biosimilar referencing Herceptin.

"This is an important milestone in the [United States] which both adds to our growing portfolio of oncology treatments and has the potential to improve access to cancer care,” said Andy Schmeltz, global president of Pfizer Oncology, in a statement. “We are proud to be able to offer treatment options that can help address the diverse needs of patients.”

Pfizer’s data package for the biosimilar included findings from the comparative clinical trial for the biosimilar, REFLECTIONS B327-02. The study found that, in patients receiving trastuzumab and paclitaxel as first-line treatment for HER2-positive metastatic breast cancer, the biosimilar showed similar efficacy, safety, immunogenicity, and pharmacokinetics (PK) to the EU-licensed reference drug. The study met its primary objective for equivalence in the objective response rate (ORR) for the biosimilar versus the reference, with the risk ratio of ORR of 0.940 (95% CI, 0.842-1.049) falling within the prespecified equivalence margin of 0.8 to 1.25.

A supplemental study of the biosimilar as neoadjuvant therapy in combination with docetaxel and carboplatin, REFLECTIONS B327-04, found no clinically meaningful differences between the biosimilar and the EU-licensed reference in terms of efficacy, safety, immunogenicity, and noninferiority in terms of PK.

The approval for Trazimera, which also earned EU authorization in July 2018, comes after Pfizer first received a Complete Response Letter from the FDA in April 2018. The company said at the time that the FDA had asked for “additional technical information,” but did not request additional clinical information or safety data.

Trazimera is the fourth trastuzumab biosimilar, following the FDA’s approval of Ontruzant, Herzuma, and Ogivri, none of which have launched in the United States.