Samsung Bioepis’ Biosimilar Transtuzumab Ontruzant (transtuzumab,dttb), Receives US FDA Approval for Oncology Indications

 Samsung Bioepis’ Biosimilar Transtuzumab Ontruzant (transtuzumab,dttb), Receives US FDA Approval for Oncology Indications

Samsung Bioepis’ Biosimilar Transtuzumab Ontruzant (transtuzumab,dttb), Receives US FDA Approval for Oncology Indications

Shots:

  • The US FDA has approved Ontruzant for all eligible indication vs reference Herceptin(transtuzumab), for adjuvant treatment of HER2-overexpressing breast cancer, metastatic breast cancer and metastatic gastric cancer or gastroesophageal junction adenocarcinoma in patients not received prior treatment for metastatic disease
  • The approval is based on clinical study results assessing Ontruzant vs Herceptin in 367 (186:181) patients with HER2 positive early/advance breast cancer. No statistically significant difference in EFS between the biosimilar arm vs reference (96.7% vs 98.2%) was found, hazard ratio was (HR, 1.19; 95% CI, 0.23-6.18; P = .8376)
  • Ontruzant (SB3) is a biosimilar transtuzumab, developed for adjuvant treatment of HER2 overexpressing breast cancer, m-breast cancer, m-gastric cancer. It  will be marketed and distributed in the US by Merck and already received EU approval in Nov 2017

Click here to read full press release/ article | Ref: BUSINESS WIRE | Image: SBS

Vartika Singh

Vartika Singh is a content writer who loves to write research articles and reports at PharmaShots. She has in-depth knowledge of the life sciences industry including the Pharma and Biotech sectors. Any articles written by her can be contacted at connect@pharmashots.com.

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