Teva gets CRL on Humira biosimilar

 Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) announced that the U.S. Food and Drug Administration (FDA) has issued a complete response letter (CRL) to its partner Alvotech (NASDAQ: ALVO) for the Biologics License Application (BLA) for AVT02, a high-concentration biosimilar candidate for Humira® (adalimumab). The CRL stated that the application could not be approved at this time based on deficiencies associated with 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 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.

https://finance.yahoo.com/news/complete-response-letter-received-avt02-005300311.html