Humira biosimilar approval paused after FDA finds ‘deficiencies’ at manufacturing facility

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’sRead More

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