Biocon - Malaysian Facility Gets Six Observations From U.S. FDA In Pre-Approval Inspection: Nirmal Bang
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Nirmal Bang Report
The U.S. Food and Drug Administration’s pre-approval inspection at Biocon Ltd.’s Malaysian facility for Insulin Aspart translated into six form 483 observations.
We do not have color on the nature of these observations, but Biocon does not expect any adverse impact on its commercialisation plans.
In our view, in the best case scenario, Insulin Aspart may be a material commercial opportunity only in FY23.
Insulin Aspart is a ~$850 million brand sales opportunity in the U.S. market and is witnessing pricing pressure.
In the most recent quarter (Q2 CY21), Insulin Aspart sales in the U.S. declined by 11% YoY.
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