FDA hits Biocon insulin biosimilar with another CRL

Indian drugmaker Biocon has received a Complete Response Letter (CRL) for its insulin aspart biosimilar product citing deficiencies at a facility in Malaysia.

According to the firm, the CRL references deficiencies from the pre-approval inspection (PAI) at its Malaysia facility in August 2022.

At the time, the US Food and Drug Administration (FDA) issued a Form 483, citing 11 observations in the production of Biocon’s insulin aspart biosimilar product.

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“The CRL did not identify any outstanding scientific issues with the product,” the firm said in a statement. “The CRL references the requirement for a satisfactory resolution of deficiencies from the pre-approval inspection (PAI) of our Malaysia facility for Insulin Aspart, held in August 2022.”

It continues: “The Company had submitted a comprehensive Corrective and Preventive Action (CAPA) plan in September 2022, that the agency found to be adequate and indicated that it would require a re-inspection of the Malaysia facility, prior to the approval of the application.”

While the product has been approved in Europe under the brand Kixelle since February 2021, Biocon has struggled to receive similar recognition in the US.

In January 2022, the FDA issued a CRL for the Biologics License Application (BLA) of insulin aspart, citing the Malaysai plant, filed by then partner Viatris (Mylan). Biocon acquired the biosimilars business of Viatris the following month for $3.3 billion.

According to Biocon, the 562,000 square-foot site in Johor, Malaysia is a Center of Excellence (CoE) for insulins, producing a broad portfolio of regular, basal, and rapid insulins.

Beyond the August 2022 Form 483, the site has received numerous other regulatory ticking offs. Most recently, an inspection between July 10 and July 20 resulted in a Form 483 with eight observations,  while in September 2021, the plant received a Form 483 from the organization with six observations.

Meanwhile, in July 2019 the plant received a Form 483 with 12 observations, several of which were repeats from a pre-approval inspection for Biocon’s insulin glargine product carried out in February 2018.  Semglee (insulin glargine), won US approval in July 2021.