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 the six biosimilar and second approved product co-developed by Biocon and Mylan . In Q2’19 Mylan plans to launch Ogivri in Canada

Ref: Biocon | Image:Pittsburgh Post-Gazette