Pfizer announced that the FDA approved Trazimera (trastuzumab-qyyp) as a biosimilar version of Roche's Herceptin (trastuzumab) for the treatment of HER2 overexpressing breast cancer and HER2 overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma. Trazimera was authorised in the EU last year in the same indications.
"This is an important milestone in the US," remarked Andy Schmeltz, global president of Pfizer Oncology. In July last year, the FDA issued a complete response letter regarding the company's application for Trazimera, with the agency citing the need for additional technical information.
According to Pfizer, the FDA's approval was based on data demonstrating "a high degree of similarity" between Trazimera and Herceptin, including findings from the REFLECTIONS B327-02 study. Results from the trial showed clinical equivalence, finding a high degree of similarity and no clinically meaningful differences between the two drugs in patients with first-line HER2 overexpressing metastatic breast cancer.
The FDA approved Mylan and Biocon's Ogivri (trastuzumab-dkst) in 2017 as the first biosimilar version of Herceptin in the US, which is expected to launch later this year. More recently, the agency authorised two further biosimilar versions of Herceptin, Celltrion's Herzuma (trastuzumab-pkrb) and Merck & Co. and Samsung Bioepis' Ontruzant (trastuzumab-dttb).
Meanwhile, last month, Roche and partner Halozyme Therapeutics gained FDA approval of Herceptin Hylecta (trastuzumab/hyaluronidase-oysk) as a subcutaneous injection for the treatment of certain patients with HER2-positive early breast cancer in combination with chemotherapy. The product can be administered in two to five minutes, versus 30 to 90 minutes for intravenous Herceptin.
For related analysis, see ViewPoints: Roche tests out Herceptin 2.0, and ViewPoints: Another US biosimilar Herceptin approval but how much does it matter?
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