Biocon cancer drug now only a step away from getting USFDA approval

Kiran Mazumdar Shaw-led Biocon is only one step away from securing the US Food and Drug Administration's (FDA's) approval for its first biologic drug.

On Thursday, the FDA's Oncologic Drug Advisory Committee (ODAC) recommended approval of Biocon's proposed biosimilar Trastuzumab, which is indicated for certain types of breast cancer. A biosimilar is a copy of an innovative biological drug.

The FDA is expected to take a call on approving Biocon's Trastuzumab by September 3 but launch in the US market may not take place until 2019 as the drug is under patent in the country. Trastuzumab is sold by drug maker Roche under