French regulator finds lapses in quality compliance at Biocon plant

MUMBAI: Biocon Ltd’s biosimilars programme for Europe has hit a roadblock with the French health regulator finding lapses in quality compliance at its Bengaluru plant during a March inspection.

In a stock exchange filing on Sunday, Biocon said the pre-approval inspection of Biocon’s drug substance and drug product sites was conducted by French National Agency for Medicines and Health Products Safety on behalf of the European Medicines Agency (EMA). The inspection was related to Biocon’s pending marketing authorisation applications for biosimilars trastuzumab and pegfilgrastim as well as for insulin glargine.

Biocon said while no critical observations were mentioned in the final report, it will get a good manufacturing practices (GMP) compliance certificate for the drug product facility only after a follow-up inspection to verify the implementation of the proposed corrective and preventive actions for the plant.

Until the drug product facility gets clearance, Biocon will not get marketing approval for its biosimilars.

The regulator, however, has issued GMP certificates for Biocon’s two drug substance manufacturing units.

Biocon did not specify the nature of the lapses.