Samsung Bioepis Receives the US FDA’s Approval for Multi-Dose Vial of Ontruzant (biosimilar, trastuzumab)

Samsung Bioepis Receives the US FDA’s Approval for Multi-Dose Vial of Ontruzant (biosimilar, trastuzumab)

Shots:

  • The US FDA has approved the 420 mg multi-dose vial of Ontruzant (trastuzumab-dttb), a biosimilar referencing Herceptin (trastuzumab) and will be marketed & distributed by Merck in the US
  • On Feb 05, 2020, Merck has announced the spin-off its biosimilar business and will continue to support the commercialization of Ontruzant until the spinoff, which is anticipated to be held in H1’21
  • Ontruzant (150 mg, single-dose vial) is an approved therapy for HER2-overexpressing BC, mBC and mGC or gastroesophageal junction adenocarcinoma in patients with prior treatment for metastatic disease

Click here ­to­ read full press release/ article | Ref: Samsung Bioepis | Image: Samsung Bioepis