Biocon Biologics' Malaysia insulin facility classified by US FDA for official action

Biocon Biologics on Wednesday said its insulin manufacturing facility in Johor, Malaysia has been classified as an official action indicated (OAI) by the U.S. Food and Drug Administration (USFDA).

The company said the OAI status may cause delay or withholding of pending product approvals from the facility.

"We submitted a comprehensive Corrective and Preventive Action (CAPA) plan to the (US)FDA in response to observations from the July inspection and believe we are on track to complete all actions as committed," said the company spokesperson in a statement to stock exchanges.


The statement added that the company will continue to engage with the agency to understand any outstanding concerns and work closely to address them expeditiously.

"We do not believe that this will have a material impact on the manufacturing and distribution of the company’s commercial products for the US market,” the spokesperson said.

Biocon's Malaysian insulins facility was inspected by the USFDA from July 10 to July 20, and issued eight observations.

The US drug regulator issued 6 observations for drug substance, drug product units and quality Control laboratories and 2 observations for the delivery devices unit of Biocon Sdn Bhd, Malaysia, a subsidiary of Biocon Biologics.

The OAI could potentially delay approval of Insulin Aspart in the US, a proposed biosimilar for diabetes treatment.

Biocon Biologics early this month said that its application for Insulin Aspart received a CRL (complete response letter) from USFDA .

"The CRL references the requirement for a satisfactory resolution of deficiencies from the pre-approval inspection (PAI) of Malaysia facility for Insulin Aspart, held in August 2022," the company said in a regulatory filing on October 7.

Shares of Biocon dropped by almost 5% and were trading at Rs 241.75 on BSE at 11.41 am on Wednesday.