Waiting For Inspections, Biocon Seeks US FDA Stance On Mutual Recognition Agreement Route

Biocon needs a pre-approval inspection for insulin aspart at its facility in Malaysia, but the surge in COVID-19 cases in the Southeast Asian nation may cloud timelines. The Indian firm is also pursuing a mutual recognition agreement route with the agency for a generic product approval.

Indian Firms Face Limited Visibility In Inspection Schedules • Source: Nielsen Hobbs

Front-line Indian companies like Biocon, Ltd. have a lot riding on regulatory inspections going through as scheduled amid pandemic-related travel restrictions to countries where plants are located.

The Bengaluru-based firm indicated that the US Food and Drug Administration had scheduled a pre-approval inspection of its manufacturing facility in Malaysia in the third quarter of calendar year 2021, in support of its biosimilar insulin aspart Biologics License Application (BLA), though investors appeared concerned

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