Trastuzumab-biosimilar Herzuma® FDA approved in HER2+ breast cancer

On 14 December 2018, the FDA approved the Herceptin®-biosimilar Herzuma® (trastuzumab-pkrb, Celltrion), a HER2/neu receptor antagonist, for patients with HER2-overexpressing (HER2+) breast cancer. Herzuma® was approved as biosimilar, not as an interchangeable product.

Mylan biosimilar trastuzumab FDA approved for HER2+ breast or metastatic gastric cancer

On 1 December 2017, the FDA approved Ogivri® (trastuzumab-dkst, Mylan) as a biosimilar to Herceptin® (trastuzumab, Genentech) for the treatment of patients with HER2-overexpressing breast or metastatic gastric or gastroesophageal junction adenocarcinoma.