FDA Approves Fourth Trastuzumab Biosimilar


Trastuzumab is indicated for the treatment of HER2 overexpressing breast cancer and HER2 overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma.

Officials with the FDA have approved trastuzumab-qyyp (Trazimera, Pfizer), a biosimilar to trastuzumab (Herceptin), according to a press release.1

Trastuzumab is indicated for the treatment of human epidermal growth factor receptor-2 (HER2) overexpressing breast cancer and HER2 overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma.

The agency’s approval of trastuzumab-qyyp was based on data, including results from the REFLECTIONS B327-02 trial, that showed a high degree of similarity between trastuzumab-qyyp and the originator product. In the study, trastuzumab-qyyp showed clinical equivalence and no clinically meaningful differences compared with the reference product in patients with first-line HER2 overexpressing metastatic breast cancer. As part of the REFLECTIONS clinical trial program, trastuzumab-qyyp has been studied in approximately 500 patients.1

The REFLECTIONS B327-02 trial included 707 participants who were randomized to receive intravenous trastuzumab-qyyp plus paclitaxel or trastuzumab plus paclitaxel, which was administered weekly with the option to change to a 3-weekly regimen from week 33. As of data cut-off, there were no meaningful differences between both treatment groups in progression-free survival (median: 12.16 months in the trastuzumab-qyyp group vs. 12.06 months in the trastuzumab group; 1-year rate: 54% versus 51%) or overall survival (median: not reached in either group; 1-year rate: 89.31% versus 87.36%). Additionally, safety outcomes and immunogenicity were similar between the treatment groups, according to the study.2

“Approximately 15% to 30% of breast cancers and 10% to 30% of gastric cancers are HER2-positive which is associated with aggressive disease and poor prognoses for patients,” Dr Mark Pegram, associate director for clinical research at the Stanford Comprehensive Cancer Institute and director of the Breast Oncology Program at the Stanford Women’s Cancer Center, said in a statement.1 “With the availability of biosimilars like Trazimera in the US, oncologists will have additional treatment options to choose from, which may help provide patients with greater access to the medicines they need.”

Trastuzumab-qyyp is the eighteenth biosimilar approved by the FDA in the United States and the fourth approved biosimilar to trastuzumab. Previous trastuzumab biosimilar approvals include trastuzumab-dttb (Ontruzant, Samsung Bioepis), trastuzumab-pkrb (Herzuma, Celltrion), and trastuzumab-dkst (Ogivri, Mylan GmbH).

Trastuzumab-qyyp was first approved for use in the European Union in July 2018.1


  • US FDA Approves Pfizer’s Oncology Biosimilar Trazimera (Trastuzumab-gyyp) a Biosimilar to Herceptin [news release]. Pfizer. https://www.pfizer.com/news/press-release/press-release-detail/u_s_fda_approves_pfizer_s_oncology_biosimilar_trazimera_trastuzumab_qyyp_a_biosimilar_to_herceptin_1. Accessed March 12, 2019.

  • Pegram MD, Bondarenko I, Hingmire S, et al. PF-05280014 (a trastuzumab biosimilar) plus paclitaxel compared with reference trastuzumab plus paclitaxel for HER2-positive metastatic breast cancer: a randomized, double-blind study. British Journal of Cancer. December 20, 2018. https://www.nature.com/articles/s41416-018-0340-2.

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