Setback for Biocon's European biosimilar plans

French regulator's observations about the formulation facilities will delay product launches

Regulatory concerns for Biocon increased after the French drug authority issued certain observations following an inspection of the Bengaluru facility.

The pre-approval inspection of drugs and products sites were related to pending European marketing authorisation applications for Biocon’s biosimilars. These include Trastuzumab (oncology drug), Pegfilgrastim (diabetes drug) and related insulin medication Glargine. With the observations, remedial actions followed by a successful re-inspection will enable the company to get a good manufacturing practice (GMP) certificate. Approvals for product launches will start only after a GMP certificate is issued.

The company said no critical observations were made in the report after inspections