FDA declines to approve Alvotech's Stelara biosimilar

The US Food and Drug Administration (FDA) has issued a complete response letter (CRL) for Icelandic firm Alvotech’s (Nasdaq: ALVO) Biologics License Application (BLA) for AVT04, a biosimilar candidate to Johnson & Johnson (NYSE: JNJ) Stelara (ustekinumab).

Alvotech said that, as expected, the CRL noted that certain deficiencies, which were conveyed following the FDA’s inspection of the company’s Reykjavik facility that concluded in March 2023, must be satisfactorily resolved before the application can be approved. No other deficiencies in the application were noted by the FDA. Alvotech intends to resubmit the BLA for AVT04 to the FDA shortly, which would likely trigger a six-month review period and a new Biosimilar User Fee Act (BsUFA) goal date.

“AVT04 has recently been approved in Japan, and other marketing applications for AVT04 are currently awaiting approval in other major markets. Based on our latest interactions with the FDA we are currently expecting that the agency will reinspect our facility in the beginning of next year. We look forward to being able to bring AVT04 to US patients, pending a satisfactory inspection and BLA approval, no later than in February 2025, in accordance with our license entry date agreement,” said Robert Wessman, chairman and chief executive of Alvotech.