After several inspections and regulatory setbacks, Alvotech has another manufacturing issue to work through.
The FDA recently wrapped up its reinspection of Alvotech’s facility in Reykjavik, Iceland, and issued yet another Form 483 filing, which flagged just one observation, the company said in a Friday release. The manufacturer plans to respond to the agency “in the following days."
“We believe that the observation is readily addressable, and we intend to respond as quickly as possible,” Alvotech CEO Robert Wessman said in the release.
Alvotech maintains that it is in a good position to finally receive approval for its Humira biosimiliar by Feb. 24 and for its Stelara option by April 16, “their respective goal dates" at the agency.
The Form 483 is the latest in a series of inspection dings for the company. In 2022, the FDA rejected the company's Humira biosimilar for the first time after finding manufacturing deviations, plus bacteria and mold at the Reykjavik site.
Then in April, the FDA doled out another complete response letter and Form 483 for the Humira copycat, this one relating to quality shortfalls, insufficient written records and computer controls, among other red flags. On the bright side, the mold and bacteria issue seemed to have been resolved.
Another rejection for the Humira biosimilar prospect came in late June after a March reinspection of the same facility.
In October, meanwhile, the FDA shot down Alvotech's Stelara candidate after uncovering “certain deficiencies” during the March inspection. That rejection was to be “expected,” Alvotech said at the time.
Alvotech has tapped Teva to take the commercial lead on the biosimilar rollouts in the U.S.
If approved, Alvotech and Teva’s Stelara biosimilar cannot launch until Feb. 21, 2025, under the terms of a settlement with Johnson & Johnson.
The Humira biosimilar candidate, meanwhile, is a high-concentration, interchangeable version of AbbVie’s best-selling drug. Teva was originally aiming for a July 1, 2023, launch date, but that plan was derailed by the manufacturing issues.
Despite the setbacks, Teva ramped up its collaboration with Alvotech last summer by pledging increased manufacturing involvement and $40 million in funding. The Israeli drugmaker committed to boost its presence at the Icelandic plant and was “actively supporting” Alvotech on-site at the time to prepare for the reinspection.