The FDA has pulled back the curtain on manufacturing flaws that recently scuttled the approval of Alvotech’s prospective Humira copycat.
In its write-up, the FDA laid out 13 observations, including chidings related to procedural controls, management of manufacturing deviations, the presence of bacteria and mold in Alvotech’s plant, plus more.
Earlier this month, Alvotech said the FDA had slapped down its potentially interchangeable biosimilar AVT02. The company said “certain deficiencies” uncovered during a March inspection of the company’s Reykjavik, Iceland, manufacturing facility, triggered the Complete Response Letter.
Now, the company is awaiting an FDA action date on the med in December and plans to “satisfactorily address” the production issues before the agency hands down its verdict, according to Alvotech’s CEO Mark Levick.
“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,” the helmsman said in a statement earlier this month.
Alvotech’s copycat has already been approved in Canada, the U.K. and in certain countries in the EU.
Interchangeability—much coveted in the world of biosimilars—means the drugs can be treated like small-molecule generics. For drugs with the tag, pharmacists can sub in the biosimilar for the reference brand right at the pharmacy counter.
But Alvotech appears to have a fair bit of work cut out in addressing the FDA’s laundry list of complaints.
“Your firm lacks procedural control to ensure that incoming materials are adequately qualified,” the FDA said at the top of Alvotech’s Form 483.
Further, Alvotech failed to kick off an investigation into its deviation management system Veeva despite the “progressively increasing trend of critical quality defects,” the regulator added.
Also of concern, Alvotech’s manufacturing spaces “are not under control for bacteria and mold,” the agency said, citing an “unacceptably high number of mold recoveries” in classified rooms used for drug substance and drug product production.
Alvotech has struggled with microbial contamination in recent years as well and has taken “inadequate” action to rectify the problem, the FDA said.
Aside from Alvotech, Boehringer Ingelheim and Pfizer are angling to launch interchangeable Humira biosimilars next year. Amgen also has a product in the running, with a trial that could yield an interchangeability tag by 2024. Organon’s partner Samsung Bioepis, for its part, has said its own interchangeable offering could surface in late 2024 or early 2025. Amgen is set to launch the first non-interchangeable Humira biosimilar in January.
AbbVie’s sales behemoth Humira pulled down revenues of $20.7 billion in 2021.