You are here: Home » Companies » News
Business Standard

Biocon partner's Cancer drug licence application gets USFDA approval

The application sought approval of Mylan's drug for treatment of patients with metastatic colorectal cancer with fluorouracil-based chemotherapy

IANS  |  Bengaluru 

pharma, medicines, drugs
The new drug will provide an affordable alternative to the branded biologic for the approved indications

The US Food and Drug Administration (FDA) has approved the biologics licence application of 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 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 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.

 

First Published: Tue, March 10 2020. 00:02 IST
RECOMMENDED FOR YOU