Biocon Malaysia Receives EMA Insulin Fill Finish Approval

Company Statement Disclosure

Key Development

Biocon Ltd. has received approval from the European Medicines Agency (EMA) for a new drug product fill finish line specifically for Semglee® (insulin glargine) at its insulin manufacturing facility located in Malaysia.

Operational Impact and Timeline

Supplies to European markets from this newly approved production line are expected to begin from the second quarter of fiscal year 2027 (Q2FY27).

Additional Information

The complete company statement is available on Biocon's official website at www.biocon.com.