Tags : Ontruzant

Biosimilars

Samsung Bioepis Launches Ontruzant (trastuzumab, biosimilar) for Early and Metastatic

Shots: The company launches its first oncology treatment Ontruzant (trastuzumab), a biosimilar referencing Herceptin in Brazil. The biosimilar has received ANVISA’s approval for the treatment of metastatic HER2-overexpressing BC, early HER2-overexpressing BC, and advanced gastric cancer Ontruzant is being supplied to SUS through a PDP b/w Samsung Bioepis & Bionovis and Bio-Manguinhos. This the second […]Read More

Biosimilars Pharma

Samsung Bioepis and Genentech Settles Patent Dispute of Trastuzumab Biosimilar-Ontruzant

Shots: Samsung Bioepis and Genentech has filed a joint stipulation of dismissal of their BPCIA patent litigation for Ontruzant, a biosimilar of Herceptin Under the settlement and license agreement, the companies jointly moved to voluntarily dismiss Bioepis’ appeal of the PTAB’s decisions upholding the patentability of U.S. Patent nos. 6,627,196 & 7,371,379, directed to cancer […]Read More

Biosimilars Biotech

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

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 […]Read More