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 authorization 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, but a newsletter by Pharmacompass, a business intelligence and connection platform for pharma companies said the 13-17 March inspection at the Bengaluru plant raised 35 deficiencies, including 11 major deficiencies.
It said the deficiencies were related to environmental monitoring and training, management of results of out-of-specification products, cleaning validation, process validation, vendors’ qualification, cross contamination risks, and batch manufacturing records, among others.
“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.
The company has also filed applications for biosimilars trastuzumab and pegfilgrastim with the US Food and Drug Administration (FDA).
Biocon expects revenue from its biologics portfolio in regulated markets such as the US and Europe to kick in from financial year 2018-19.