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

Ref: BUSINESS WIRE | Image: Samsung Bioepis