Biocon Thursday announced the US Food and Drug Administration has accepted Mylan’s Biologics License Application (BLA) for biosimilar chemotherapy drug Pegfilgrastim for review. Mylan is Biocon’s partner for biosimilar development.
Sharing details on the development with CNBC-TV18 Biocon Chairperson and Managing Director Kiran Mazumdar Shaw said, "This is a very important acceptance."
However, the drug will not be launched immediately as there could be certain patent challenges, she added.
She expects the launch in financial year 2018 or 2019.
She said the USD-3.5-billion US market, is the biggest for the company and that biosimilars will contribute to company’s topline growth exponentially.
Pegfilgrastim is an anti-cancer drug used to reduce the chance of infection due to low white blood cell count and incidence of fever in people treated with chemotherapy in certain types of cancer.
This is the second Biocon application accepted by USFDA. Earlier, the drug regulator had accepted Mylan-Biocon’s application for biosimilar trastuzumab, used in the treatment of breast cancer.
In a stock exchange filing, Biocon said the goal date set by the US FDA under the Biosimilar User Fee Act is 9 October, 2017.