The copycat version of AbbVie’s blockbuster still has court clearance to launch on July 1, but only if regulators have approved it.

For a second time, the Food and Drug Administration has rejected Alvotech’s Humira biosimilar, citing deficiencies spotted during a March inspection of its manufacturing facility in Iceland, the company said Thursday.

The agency’s decision comes less than three months before Alvotech is free to launch the drug in the U.S. under a settlement with AbbVie, Humira’s manufacturer. Alvotech has a second FDA application pending that, if approved by June 28, would make it one of the first “interchangeable” Humira biosimilars, meaning pharmacists could directly substitute it for the branded product.

An expected launch on July 1 could be delayed if the FDA doesn’t grant the main approval, which would clear the biosimilar for sale in the U.S. In a statement Thursday evening, Alvotech said it provided responses to FDA inspectors on April 3 and is awaiting feedback from the agency, which previously rejected its approval request in September because of manufacturing issues. Its shares fell 20% midday Friday.

The FDA has approved eight biosimilar versions of Humira, the most lucrative pharmaceutical product in the industry’s history. One, Amgen’s Amjevita, launched in January, and seven more approved products could follow around July 1, including one other interchangeable version, Boehringer Ingelheim’s Cyltezo.

Joining these seven in July will be crucial for Alvotech and its marketing partner, Teva Pharmaceutical, to gain market share — particularly because Alvotech’s version comes in the most-used Humira formulation, while Cyltezo doesn’t.  

Biosimilar manufacturers are gunning for Humira, global sales of which peaked at $21 billion in 2022. Because of strong sales in the U.S., AbbVie and its former parent company, Abbott Laboratories, were able to grow revenue almost non-stop for 20 years through 2022. (Biosimilar versions arrived in Europe in 2018 and ate into Humira’s market share.)

Alvotech’s announcement came amid a flurry of manufacturing-related setbacks for drugmakers. Contract manufacturer Catalent cited “productivity issues and higher-than-expected costs experienced at three of its facilities” in lowering its revenue forecasts for the third quarter. The FDA also declined to approve Eli Lilly’s ulcerative colitis drug mirikizumab due to manufacturing issues at one of its facilities.

Reference：

https://www.biopharmadive.com/news/alvotech-humira-biosimilar-second-fda-rejection/647691/