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Trastuzumab-biosimilar Ontruzant® FDA approved in several indications

On 18 January 2019, the FDA approved the Herceptin®-biosimilar Ontruzant® (trastuzumab-dttb, Samsung BioEpsis), a HER2/neu receptor antagonist, for patients with HER2-overexpressing (HER2+) breast cancer in the adjuvant and metastatic setting, and in metastatic HER2+ gastric cancer patients. Ontruzant® was approved as biosimilar, not as an interchangeable product.

Biosimilar epoetin alfa-epbx approved by FDA for the treatment of anemia due to chronic kidney disease, use of zidovudine for HIV, and concomitant myelosuppressive chemotherapy

 

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.