Bengaluru plant of Biocon receives EIR

The US drug regulator, USFDA has cleared Biocon's sterile drug product unit after an inspection that ended last month.

Biocon has received an Establishment Inspection Report (EIR) for the facility that notified that the inspection stands closed. The US Food and Drug Administration inspected the unit in April and May 2018 as part of the pre-approval process for pegfilgrastim, a biosimiliar drug. The drug is used as white cell booster for cancer patients undergoing chemotherapy.

The positive development comes when the company is working together gaining a solid footing in the US biosimiliar market with the development of drugs including trastuzumab, pegfilgrastim and insulin glargine.

Meanwhile, at 10:54 hours, the stock of Biocon was quoting Rs. 636.50 per share, up by 1.28 per cent, when the benchmark S&P BSE Sensex was at 35,655.70, down 33.90 points or 0.09 per cent on Monday.