Humira biosimilar approval paused after FDA finds ‘deficiencies’ at manufacturing facility
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The FDA approval of Alvotech’s Humira biosimilar is on hold until the company can address “certain deficiencies” the administration found during an inspection of a manufacturing facility, according to a press release.
A statement released by the company said it had received a message from the FDA detailing the administration’s March 2022 inspection of Alvotech’s manufacturing facility in Reykjavik, Iceland. According to the statement, the FDA noted “certain deficiencies” during that inspection as part of its complete response letter to Alvotech’s initial biologics license application (BLA) for its adalimumab (Humira, AbbVie) biosimilar AVT02. The letter added that a satisfactory resolution to these deficiencies would be required before the FDA may approve the application for AVT02.
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“Alvotech looks forward to addressing the deficiencies outlined in the post-application action letter and continuing to work with the FDA to close out the facility inspection,” Mark Levick, CEO of Alvotech, said in the statement. “We aim to satisfactorily address the issues before the Biosimilar User Fee Act (BSUFA) goal date for the interchangeable biosimilar BLA in December.”
Alvotech is one of nine companies that have settled with Humira manufacturer AbbVie to allow the eventual release of adalimumab biosimilars in the United States come 2023 — the end result of years of legal wrangling and delays over copyright. According to the court settlement, Alvotech’s AVT02 can legally be released in the United States on July 1, 2023. However, it will need to be approved by the FDA first.
“We are committed to bringing AVT02 to patients worldwide and anticipate being launch ready by our expected launch date in the United States of July 1, 2023,” Levick said in the release.
If approved, it will have to share its U.S. debut with at least one other Humira biosimilar. Cyltezo (adalimumab-adbm, Boehringer Ingelheim), which was approved by the FDA in 2017 and later deemed interchangeable with the reference product in 2021, is also scheduled for a settlement-mandated U.S. release on July 1, 2023.
In fact, all seven Humira biosimilars currently approved by the FDA are slated for a 2023 release in the United States. Besides Cyltezo, they include Amjevita (adalimumab-atto, Amgen), Hyrimoz (adalimumab-adaz, Novartis Sandoz), Hadlima (adalimumab-bwwd, Samsung Bioepis), Abrilada (adalimumab-afzb, Pfizer), Hulio (adalimumab-fkjp, Mylan) and Yusimry (adalimumab-aqvh, Coherus BioSciences).
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