Biocon Gets U.S. FDA Establishment Inspection Report For Bengaluru Biologics Unit
US FDA’s EIR for Biocon Biologics’ Bengaluru unit reaffirms its manufacturing capabilities for high-quality biosimilars, CEO says.
Biopharmaceutical firm Biocon Ltd. on Tuesday said it has received an establishment inspection report from the U.S. Food and Drug Admininstration for its biologics drug product unit at Bengaluru.
The Kiran Mazumdar Shaw-led drugmaker had undergone good manufacturing norms compliance inspection of the unit from Aug. 22-30, Biocon said in a regulatory filing. The U.S. FDA has said the inspection is closed.
"The EIR for this facility reaffirms our manufacturing capabilities for high quality biosimilars to serve the needs of patients in the U.S." Christine Hamacher, chief executive officer at Biocon Biologics, said.
The facility is strategic to Biocon’s $1 billion revenue target, Hamacher added.
The U.S. FDA had in October approved Biocon's new drug product filing for biosimilar Trastuzumab 150 mg vials at the biologics unit in Bengaluru following a pre-approval inspection in September, the company said.
On Tuesday, Biocon shares fell 2.98 percent to Rs 255.85 apiece on the BSE while the benchmark Sensex rose shed 0.13 percent to end the day at 40,248.23 points.
(Corrected the headline to say Biocon received EIR and not observations.)