ET Bureau Dec 02, 2019, 06.45 PM IST
Biocon and its partner Mylan have jointly launched cancer drug Ogivri, a biosimilar to Herceptin, in the US. The Bengaluru-headquaratred biotech company said the Trastuzumab biosimilar, co-developed by Biocon Biologics, a Biocon subsidiary, and Mylan, was unanimously recommended by the FDA Oncologic Drugs Advisory Committee.
Ogivri, available in a 420mg multi-dose vial and a 150mg single-dose vial, will be used for treatment of all types of breast cancer and metastatic stomach cancer (gastric or gastroesophageal junction adenocarcinoma).
Mylan and Biocon Biologics have sufficient manufacturing capacity to fulfil demand in the US and global markets for both products, said Biocon in a press release.
“The US launch of Ogivri, the biosimilar trastuzumab marks a significant milestone in our biosimilars journey. It is an important endorsement of our science, development and manufacturing capabilities in the area of monoclonal antibodies. The introduction of both 420mg multi-use vials and 150mg single-use vials of a high quality biosimilar trastuzumab with robust long-term efficacy and safety data will offer greater choice and value to patients, prescribers and payors in the US,” Christiane Hamacher, CEO, Biocon Biologics, was quoted saying.