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