Tags : Ogivri

Mylan and Biocon Launch Ogivri (biosimilar, trastuzumab) in the US

Shots: The FDA’s approval is based on study assessing Ogivri vs Herceptin with docetaxel or paclitaxel in 456 patients with measurable HER2+ mBC without prior chemotherapy or trastuzumab for metastatic disease The study demonstrated equivalence in overall response @24wks. with equivalence margin (0.81, 1.24) showing no clinically meaningful differences in terms of safety, purity and […]Read More

Mylan and Biocon Launch Ogivri (biosimilar, trastuzumab) in Australia

Shots: Ogivri is the first biosimilar to Herceptin (trastuzumab) to be approved and launched in Australia for the treatment of HER2-overexpressing breast cancer and metastatic stomach cancer and will be available on the Pharmaceutical Benefits Scheme The TGA’s approval of Ogivri is based on data which demonstrated bio-similarity to Herceptin with no clinically meaningful differences […]Read More

Biocon and Mylan’s Ogivri (trastuzumab, biosimilar) Receives Health Canada’s Approval

Shots: The approval is based on study assessing Ogivri vs Herceptin (trastuzumab) in patients evaluating its safety, efficacy, PK and immunogenicity The study resulted with no clinical difference in safety, efficacy and potency between Ogivri and Herceptin Ogivri (trastuzumab, biosimilar) is a mAb, currently approved in 65 countries including the US. Ogivri is one of […]Read More