FDA approves Trazimera, a biosimilar to Herceptin

12 March 2019

The US Food and Drug Administration has approved Trazimera (trastuzumab-qyyp), a biosimilar to Herceptin (trastuzumab), for the treatment of human epidermal growth factor receptor-2 (HER2) overexpressing breast cancer and HER2 overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma.

Developed by US pharma giant Pfizer (NYSE: PFE), Trazimera received European approval in July last year,joining the ranks of Samsung Bioepis, Amgen (Nasdaq: AMGN) and Celltrion (KRX: 068270) in the crowded field of copycats to Roche’s (ROG: SIX) blockbuster cancer drug Herceptin.

In January, the FDA, which has been relatively slow in clearing biosimilars, approved Samsung Bioepis’ Ontruzant Herceptin Hylecta (trastuzumab and hyaluronidase-oysk), adding to Teva Pharmaceutical's Herzuma and Mylan's Ogivri, but none of these have yet launched in the USA, where the Herceptin patent is not due to lapse until mid-June..

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