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
Shots: The four-year follow-up data is part of the ongoing follow-up study, assessing the cardiac safety and survival outcome of Ontruzant vs Herceptin in a subgroup of patients from P-III study with completed neoadjuvant and adjuvant therapy for 1yr. 367 out of 875 patients were enrolled in the extension study, with a median follow-up of […]Read More
Shots: Merck reports the launch of Ontruzant (trastuzumab-dttb), a biosimilar referencing Herceptin and will be available in both 150mg single-dose vials at a WAC of ~$1,325 and 420mg multiple-dose vials at a WAC of ~ $3,709, representing a 15% discount to the current list price of Herceptin The biosimilar is being launched as a part […]Read More
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 […]Read More
Shots: The P-III study involves assessing of SB3 vs Herceptin in 208 Chinese breast cancer patients and plans to evaluate its safety and efficacy Samsung plans to conduct the trial in collaboration with AffaMed Therapeutics, a Chinese venture established by C-Bridge Capital Ontruzant is a (biosimilar, trastuzumab) and is targeted to treat patients with early […]Read More
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
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
Copyright ©2021 PharmaShots | Powered by Octavus Consulting
