FDA rejects Alvotech's Humira copycat on manufacturing issues

The FDA rejected Alvotech’s application to approve its biosimilar copycat drug of AbbVie’s blockbuster immunology asset Humira after an inspection of the company’s Reykjavik, Iceland, manufacturing plant.

The regulatory agency issued a complete response letter to Alvotech following a March inspection. The letter cited “certain deficiencies” at the facility, the company said in a press release, though it didn’t detail what the issues were.

Alvotech’s copycat is under evaluation for biosimilarity and interchangeability to Humira (adalimumab), which inhibits tumor necrosis factor. AVT02 was approved by the EU and in Norway, Iceland, Lichtenstein, the U.K., Switzerland and Canada.

“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, Alvotech’s chief executive, said in the release. “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.”

In addition to the Alvotech push, Boehringer Ingelheim and Pfizer are expected to launch interchangeable Humira biosimilars next year. Amgen is also in the running with a trial that could lead to an interchangeability label by early 2024. And Organon’s partner Samsung Bioepis has said an interchangeable offering could be possible around late 2024 or early 2025.

AbbVie amassed $20.7 billion in sales of Humira in 2021.