Pfizer's Trastuzumab Biosimilar, Trazimera, Authorized by European Commission

Pfizer announced today that the European Commission (EC) has approved its trastuzumab biosimilar, Trazimera, referencing Herceptin, for marketing. The approval makes Trazimera the fourth trastuzumab biosimilar (following Kanjinti, Ontruzant, and Herzuma) to be approved by the EC, and the first approval of an anticancer biosimilar for Pfizer.

Today’s approval allows the drug to be marketed in the 28 member states of the European Union as well as in the European Economic Area. The biosimilar has been approved to treat HER2-positive breast cancer, metastatic gastric cancer, and gastroesophageal junction adenocarcinoma, the same indications as its reference product.

In a statement, Diana Lüftner, Dr med, of the Charité Campus Benjamin Franklin in Berlin, Germany, and member of the presidency of the German Society of Hematology and Medical Oncology, hailed the approval, saying that the biosimilar “has the potential to help many patients with HER2-overexpressing cancers, such as breast and gastric, which can correlate with poor outcomes and aggressive disease. Today’s approval will help enable greater access for patients and physicians across Europe, without compromising on quality, efficacy and safety.”

The approval follows a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) in June 2018, which relied on a data package that included results from Pfizer’s phase 3 REFLECTIONS B327-02 study, results of which were presented at the European Society for Medical Oncology conference in 2017. The study, in 707 patients with HER2-positive metastatic breast cancer, found that Pfizer’s biosimilar was similar to EU-licensed trastuzumab in terms of efficacy, safety, immunogenicity, and pharmacokinetics when used as first-line treatment.

While Pfizer has cleared the final regulatory hurdle for its product in the European market, in April 2018, Pfizer received a Complete Response Letter from the FDA for the same molecule. The company says that the FDA highlighted the need for “additional technical information,” and that the agency did not request information related to safety or clinical data submitted in the Biologics License Application. Pfizer indicated that it will work closely with the FDA to address the letter’s contents and that it remains committed to developing the product.

In the United States, only 1 trastuzumab biosimilar, Mylan and Biocon’s Ogivri, has received approval from the FDA. No launch date has been announced for the drug.