Biocon’s insulin copycat aspart hit another roadblock as the FDA issued a complete response letter (CRL), saying the Malaysia production facility still must undergo a pre-approval inspection to resolve problems discovered in a 2022 inspection.
The notice from the FDA did not identify any outstanding scientific issues with the product, Biocon said.
During the August 2022 visit to Biocon’s Johor, Malaysia plant FDA inspectors found six observations. More recently, a July inspection of the facility from the U.S. federal agency resulted in a Form 483 filing that cited ongoing issues such as scissors stored in non-sterile holders being used to open “bags of sterile components," improper blockage of air filters, insufficient cleaning of sterile machinery and numerous problems with batch testing and record-keeping.
Biocon submitted a corrective and preventive action plan (CAPA) in September 2022 in the wake of the August inspection that the FDA found to be adequate and said the agency would require a re-inspection of the Malaysia facility, prior to the approval of the application, the company said in an Oct. 7 filing (PDF) with the BSE and the National Stock Exchange of India.
“In February 2023, the Company submitted a report from an independent third-party consultant, providing evidence of CAPA completion and effectiveness, Biocon said in its filing. “However, the PAI re-inspection was not scheduled prior to the goal date of October 6, 2023.”
“The Company will continue to engage with the US FDA for an expeditious resolution and approval of its biosimilar Insulin Aspart application,” the company added. “This decision has no impact on the manufacturing or distribution of the Company’s existing commercial portfolio.”
Biocon went all in on biosimilars when one of its subsidiaries shelled out $3.3 billion of cash and stock in February 2022 to buy Viatris’ biosimilars franchise.