Bengaluru, The US Food and Drug Administration (FDA) has approved the biologics licence application of Biocon partner Mylan for review, according to the biotech firm here on Monday.
“The application sought approval of Mylan’s drug for treatment of patients with metastatic colorectal cancer with fluorouracil-based chemotherapy,” said the city-based Biocon in a statement.
The proposed medicine (bevacizumab) is expected to be the third type from the partnered portfolio for cancer patients in the US. It is available in India and other developing markets.
“The US regulator’s acceptance of the application for the drug, co-developed by our Biologics and Mylan, will facilitate access to affordable cancer therapies for patients,” said Biocon Biologics chief executive Christiane Hamacher.
The new drug will provide an affordable alternative to the branded biologic for the approved indications.
“Biologics’ R&D and manufacturing capabilities have enabled us to offer two biosimilars to cancer patients in the US and bevacizumab will expand our oncology portfolio,” Hamacher said.