Alvotech Gets FDA Letter, Expects Delay in U.S. Approval of AVT02

By Mary de Wet

Alvotech said Wednesday that approval for AVT02, a biosimilar candidate for Abbvie's Humira, in the U.S. is likely to be delayed after the Icelandic company received a complete response letter from the Food and Drug Administration.

As a result, Alvotech said it would explore options to raise additional capital to continue advancing pipeline development in the near term.

ATP Holdings, a unit of Alvotech's largest shareholder, Aztiq, is interested in providing as much as $100 million from potential financing, Alvotech said.

The FDA letter was in response to the company's second biologics license application. In April, the FDA sent Alvotech a complete response letter for its initial application, which noted certain deficiencies at the company's Reykjavik facility.

Alvotech said it intends to resubmit the biologics license application for AVT02.

Write to Mary de Wet at mary.dewet@dowjones.com

(END) Dow Jones Newswires

June 28, 2023 19:48 ET (23:48 GMT)

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