French health regulator ANSM (French National Agency for Medicines and Health Products Safety) found lapses in quality compliance at Indian biopharmaceutical company plant during its inspection in March this year.
Biopharmaceutical company, Biocon, said that the French regulatory agency had conducted pre-approval inspection audits of its drug substance and drug product manufacturing facilities in Bangalore on behalf of the European Medicines Agency (EMA).
The inspections related to the pending EMA marketing authorisation applications by Biocon for its biosimilar products Trastuzumab, pegfilgrastim and insulin glargine.
The company said that ANSM made no critical observations in its final report but proposed a few corrective actions. ANSM has informed it that a follow-up inspection would be required by the French agency to verify if these actions were being implemented before issuing a good manufacturing practices (GMP) compliance certificate for its products facility, Biocon said.
“ANSM has reviewed the proposed Corrective and preventive action (CAPA) plan and Biocon is progressing towards completion of the implementation of these CAPAs,” Biocon said.
Until the drug product facility gets clearance, Biocon will not get marketing approval for its biosimilars. The French regulator, however, has issued GMP certificates for Biocon’s two drug substance manufacturing units in Bengaluru. The company said that the manufacture of these two substances is crucial to the production of the actual biologic product relating to GMP compliance.
While Biocon did not specify the nature of the lapses, the March 13-17 inspection at the Bengaluru plant raised 35 deficiencies, including 11 major deficiencies.
“Biocon, along with its partner Mylan, will work with the French and European regulatory authorities with regard to the follow-up inspection of the drug product facility and the marketing authorisation applications with the goal of an early re-inspection,” Biocon said in the filing.