In March 2019, the FDA approved Trazimera (trastuzumab-qyyp; from Pfizer) as the fourth biosimilar to Herceptin (trastuzumab; from Genentech) for the treatment of patients with HER2-positive metastatic gastric or gastroesophageal junction adenocarcinoma or HER2-positive breast cancer. This approval was based on several studies confirming that Trazimera is biosimilar to the original drug, Herceptin.
Biosimilars are drugs that contain the same components of an original (brand-name) drug, such as Herceptin, which was previously approved by the FDA. Biosimilars offer the same treatment benefit, but at a reduced cost, usually about 15% to 30% lower than the cost of the original drug.
Earlier, in January 2019, the FDA approved the third biosimilar to Herceptin, Ontruzant (trastuzumab-dttb; from Merck), also for patients with HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma or HER2-positive breast cancer or HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma.
