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Kiran Mazumdar Shaw, chairman and managing director of Biocon says that India's largest Biopharma company will take remedial measures at its drug product facility within a quarter and ask the French medical regulator to inspect its facility again to get certified for good manufacturing practice (GMP).
Biocon has filed for regulatory approvals to market its biosimilars =- Trastuzumab and Pegfilgrastim, in the highly regulated European market with the European Medicines Agency (EMA). French National Agency for Medicines and Health Products Safety or ANSM conducted the mandatory site inspections on behalf of EMA as part of its pre approval procedures.
"There are no data integrity issues and no product quality issues. The concerns that they have expressed, we are taking remedial measures in short time, within a quarter and as soon as we are ready, we will ask them for a re-inspection," said Shaw. "There will be no material impact"
ANSM had conducted audits in March and approved GMP compliance certificate for two drug substance facilities and insulin Glargine pen facility.
Biocon is looking to enter the highly regulated European and US markets with its biosimilars by next fiscal. For this, it had filed marketing authorization application with the European regulators. In February, its joint Biologics License Application with Mylan for biosimilars was accepted by the US Food and Drugs Administration (FDA).
Biocon stock had closed Rs 15.80 or 4.69 per cent down at Rs 321.25 on the Bombay Stock Exchange on Monday. (EOM)