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Biocon Insulin Plant Gets FDA Form 483s As Aspart Awaits Action

Six Observations Issued By US Agency Following On-Site Pre-Approval Inspection

 
• By Dave Wallace

Six Form 483 observations of GMP deficiencies have been received from the US FDA by Biocon after the agency inspected the Malaysian manufacturing facility for its insulin aspart biosimilar. However, the Indian firm – which is partnered with Viatris on the product, for which an interchangeability designation is also being sought – insisted that US commercialization plans would not be affected.

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Biocon’s insulin aspart plant has received six Form 483 observations • Source: Alamy

Biocon has received from the US Food and Drug Administration six Form 483 observations of deficiencies at its biosimilar insulin aspart manufacturing facility in Malaysia, following an on-site pre-approval inspection conducted by the agency.

However, the Indian firm – which is partnered with Viatris on insulin aspart, with the company having indicated earlier this year that FDA action on its application for the product, as well as for an accompanying interchangeability designation, was due in

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