BRIEF—CRL received for AVT02 Biologics License Application

Israeli generics giant Teva Pharmaceutical Industries announced that the US Food and Drug Administration (FDA) has issued a complete response letter (CRL) to its partner Alvotech for the Biologics License Application (BLA) for AVT02, a high-concentration biosimilar candidate for AbbVie’s Humira (adalimumab).

The CRL stated that the application could not be approved at this time based on deficiencies associated with Iceland-based Alvotech’s manufacturing facility that must be satisfactorily resolved.

Additional review of the details following the recent FDA’s re-inspection and CRL are being assessed to determine next steps.

While this outcome is disappointing, Teva says it remains fully committed to its leadership in biosimilars and the partnership with Alvotech.

The Company remains optimistic about additional compounds in the pipeline and further progress with AVT02.

Last year, Alvotech executed a US settlement agreement with AbbVie that grants Alvotech non-exclusive rights to market AVT02 in the USA.

The settlement granted Alvotech a license entry date in the USA of July 1, 2023.