Biocon Biologics gets EIR from USFDA for Bengaluru facility

Biocon Limited’s subsidiary Biocon Biologics India Ltd has received an establishment inspection report (EIR) from USFDA for the pre-approval inspection (PAI) at two of its biologics manufacturing facilities in Bengaluru.

The inspection was conducted between September 10 and September 19, 2019. Biocon Biologics has responded to the regulator on the eight observations from this inspection, in the month of October 2019.

Subsequent to the above inspection, Biocon Biologics has received approvals for the two products Trastuzumab (drug product) and Pegfilgrastim (drug substance) from USFDA in 2019. The receipt of the establishment inspection report (EIR) indicates a successful closure of the inspection. 

The formal closure of USFDA inspection is expected to enable filing of marketing authorisation applications for its biosimilar products in several global markets.

This week, Biocon and Mylan NV together launched Fulphila, a biosimilar of Neulasta (pegfilgrastim) in Australia.

On Thursday, the stock of Biocon opened at Rs 340. During the early morning session, it surged 4.7 per cent to Rs 352.80 from its previous close of Rs 336.90 on BSE.