Alvotech, the Reykjavik-based pharmaceutical manufacturer, finds itself grappling with another regulatory stumbling block, as the FDA recently concluded its reinspection of the company’s facility, leading to the issuance of a Form 483 filing. This development adds another layer of complexity to the series of inspections and manufacturing intricacies that have characterized Alvotech’s recent history.
In a statement, Alvotech disclosed that the FDA had identified a solitary observation during the inspection. CEO Robert Wessman expressed confidence in the company’s ability to swiftly address the identified concern, stating, “We believe that the observation is readily addressable, and we intend to respond as expeditiously as possible.”
This latest Form 483 filing is part of an overarching pattern of inspection challenges for Alvotech. The FDA’s initial rejection of the company’s Humira biosimilar in 2022 was grounded in manufacturing deviations and the detection of bacteria and mold at the Reykjavik site.
Subsequent setbacks included complete response letters and Form 483s issued in April, citing quality shortfalls, inadequacies in written records, and issues with computer controls related to the Humira copycat. While the concerns related to mold and bacteria appeared to have been successfully mitigated, the company faced yet another rejection for the Humira biosimilar in late June following a March reinspection.
The challenges persisted in October, with the FDA rejecting Alvotech’s Stelara candidate due to identified “certain deficiencies” during a March inspection. Alvotech had foreseen this rejection, categorizing it as “expected” at the time.
Despite these impediments, Alvotech remains sanguine about securing FDA approval for its Humira biosimilar by February 24 and its Stelara option by April 16, aligning with the agency’s specified goal dates.
In navigating these intricate regulatory challenges, Alvotech has enlisted the collaboration of Teva to spearhead the commercial rollout of the biosimilars in the U.S. However, even if approved, the launch of Alvotech and Teva’s Stelara biosimilar is subject to restriction until February 21, 2025, in accordance with the terms of a settlement reached with Johnson & Johnson.
The Humira biosimilar candidate, positioned as a high-concentration, interchangeable iteration of AbbVie’s flagship drug, faced a setback in Teva’s initial launch plan of July 1, 2023, due to manufacturing issues.
To bolster their efforts, Teva augmented its collaboration with Alvotech last summer, committing to increased manufacturing involvement and injecting a substantial $40 million in funding. The Israeli drugmaker also pledged to enhance its on-site presence at the Icelandic plant, actively supporting Alvotech in readiness for the subsequent reinspection.
