Biocon hit by FDA 483 with 6 observations at Malaysian plant

Biocon’s insulin manufacturing facility in Malaysia has received a US FDA Form 483 with six observations but firm says it will not affect commercialization plans in the US.

Indian biopharma giant Biocon reported this week it has been issued with a Form 483 by the US Food and Drug Administration (FDA) after the agency conducted an on-site pre-approval inspection (PAI) at its Malaysian  manufacturing plant for its biosimilar insulin product.

“The US FDA conducted a (PAI) of our Malaysian subsidiary Biocon Sdn Bhd’s manufacturing facility for Insulin Aspart between Sep 13 and Sep 24, 2021. At the conclusion of the inspection, the agency has issued a Form 483 with a total of six observations across drug substance, drug product and devices facilities,” a company spokesperson said in a statement.

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Specifics of the six observations have not been disclosed but the firm remains positive that it can address the identified issues with procedural enhancements and a Corrective and Preventive Action Plan (CAPA), which will be submitted to the FDA in the required time.

“We do not expect the outcome of this inspection to impact our commercialization plans for insulin Aspart in the US. Biocon Biologics remains committed to global standards of quality and compliance,” said the spokesperson.

Biocon and Mylan (now part of Viatris) developed insulin aspart Kirsty (previously Kixelle), which is a biosimilar of Novo Nordisk’s NovoRapid. Kirsty received authorization by the European Medicines Agency in February.

The same facility received a US FDA Form 483 with twelve observations in July 2019, which the firm said were not critical but rather procedural deviations due to human error. Biocon told us that there are no systemic manufacturing issues at this plant but instead, the inspection process is a common occurrence in the biosimilars approval process.