Teva’s dream of a smooth summer launch for its Alvotech-partnered Humira biosimilar is in jeopardy after its Icelandic compatriot weathered a second FDA snub in less than a year.
Manufacturing deficits have triggered a second complete response letter in Teva and Alvotech’s quest for approval of AVT02, a high-concentration biosimilar candidate to Humira, the companies said Friday. The FDA flagged deficiencies after reinspecting Alvotech’s Reykjavik, Iceland, production plant. The regulator’s return visit to Alvotech’s facility wrapped up March 17 and followed a prior inspection in 2022.
Last year, the FDA rejected Alvotech’s biosimilar application after finding manufacturing deviations, the presence of bacteria and mold in the Reykjavik plant and more.
The latest Form 483, which followed a March 2023 inspection of the same Alvotech facility, cited issues pertaining to quality shortfalls, subpar written records, problems with incoming stoppers and insufficient computer controls, among other manufacturing gaps. The mold and bacteria issue cited in the regulator’s previous write-up did not reappear in the most recent form 483, suggesting Alvotech had resolved the matter.
Alvotech says it sent the FDA a “comprehensive” response on April 3. Meanwhile, the latest setback has delayed the timing of a potential approval on AVT02, with the FDA now set to deliver its verdict by June 28.
“Satisfactory outcome of the facility reinspection remains the key requirement for approval,” Alvotech noted in a press release.
Teva had been planning to launch the biosimilar—potentially with a coveted interchangeability tag—on July 1. Alvotech’s repeat rejection now leaves a tight window for the companies to achieve that goal.
The age of the Humira biosimilar arrived early this year with the entrance of Amgen’s copycat Amjevita. Seven other prospects are waiting in the wings, though Amgen is enjoying a half-year head start thanks to a 2017 settlement with AbbVie.
Aside from Amgen, Alvotech and Teva, companies like Boehringer Ingelheim, Coherus, Fresenius Kabi, Pfizer, Samsung Bioepis and Organon, Sandoz, and Viatris are also hoping for a piece of the Humira pie this year.
In the U.S. alone, Humira pulled down $18.62 billion in sales last year. Biosimilars have been eating away at the drug's international sales for several years.
Editor’s Note: This story has been updated with additional information from the FDA's March 2023 inspection of Alvotech's Reykjavik, Iceland manufacturing facility.