Alvotech fails pre-approval inspection for its proposed Humira interchangeable biosimilar

Almost a dozen new Humira biosimilars will finally launch in the US next year, beginning with Amgen’s in January (almost four years behind Europe), but one of the top follow-on contenders, with a higher concentration version and a potential interchangeable designation to boot, has now been stalled due to manufacturing issues.

Mark Levick

Alvotech revealed Monday that the FDA sent along a rejection letter that identified “certain deficiencies related to the Reykjavik facility and stated that satisfactory resolution of the deficiencies is required before FDA may approve” the biosimilar application.

“We aim to satisfactorily address the issues before the Biosimilar User Fee Act (BSUFA) goal date for the interchangeable biosimilar BLA in December,” Mark Levick, CEO of Alvotech, said in a statement. “We are committed to bringing AVT02 to patients worldwide and anticipate being launch ready by our expected launch date in the U.S. of July 1, 2023.”

Alvotech recently outlined in its earnings call last week who it believes to be its top 3 competitors in this $20 billion+ space, where the FDA has now approved seven biosimilars to Humira.

Icelandic billionaire and Alvotech founder Róbert Wessman previously touted the company’s ability to be first-to-market in the US with this higher-concentrated biosimilar of Humira, which is what AbbVie currently uses. But whether the company now gets there may come down to its ability to correct manufacturing issues.

Alvotech also recently launched its Humira biosimilar in Canada and Europe, where competition has been fierce.

In Europe, biosimilars have captured more than half of the market and brought down the price of Humira by more than 50% in some countries.

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