Biocon Biologics India, a subsidiary of Biocon has received the Establishment Inspection Report (EIR) from the US FDA 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 the US FDA in 2019. The receipt of the Establishment Inspection Report (EIR) indicates a successful closure of the inspection, states a company release.
The formal closure of the US FDA inspection is expected to enable filing of marketing authorisation applications for our biosimilar products in several global markets, stated the company.