Alvotech fails pre-approval inspection for its proposed Humira interchangeable biosimilar
Almost a dozen new Humira biosimilars will finally launch in the US next year, beginning with Amgen’s in January (almost four years behind Europe), but one of the top follow-on contenders, with a higher concentration version and a potential interchangeable designation to boot, has now been stalled due to manufacturing issues.
Alvotech revealed Monday that the FDA sent along a rejection letter that identified “certain deficiencies related to the Reykjavik facility and stated that satisfactory resolution of the deficiencies is required before FDA may approve” the biosimilar application.
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