Eye on Pharma: Pfizer Launches Trazimera in Spain

Pfizer has launched its biosimilar trastuzumab, Trazimera, in Spain. The biosimilar became available to Spanish patients with early and locally advanced or metastatic HER2-positive breast cancer and HER2-positive metastatic gastric cancer on April 1, 2019.

César A. Rodríguez, MD, of the department of medical oncology at the University Hospital of Salamanca, said in a statement that the biosimilar will increase access to innovative therapies; the availability of a lower-cost trastuzumab option will allow for the better management of resources, he said, allowing more people to be treated.

Miguel Angel Calleja, PharmD, head of pharmacy at the Hospital Virgen Macarena de Sevilla, added that, in addition to the biosimilar’s demonstrated efficacy and safety, the product provides an advantage because it can be stored without the need for a cold chain for a period of 3 months, thereby reducing hospital staff workload.

Trazimera was approved for marketing in the European Union in July 2018, making it the fourth biosimilar trastuzumab to receive the European Commission (EC)’s clearance, following Ontruzant, Herzuma, and Kanjinti; later, the EC approved Ogivri, the fifth EU biosimilar trastuzumab.

Trazimera has also been approved by the FDA; in March 2019, Trazimera became the fourth US-approved biosimilar trastuzumab, following Ontruzant, Herzuma, and Ogivri. However, no biosimilar trastuzumab products have yet launched in the United States.

Trazimera’s data package that led to approval 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.

No US launch date for the biosimilar has been disclosed.