Newly public Alvotech says it anticipates being “launch ready” by the firm’s expected US launch on 1 July 2023 for its proposed AVT02 biosimilar to Humira (adalimumab), despite a US Food and Drug Administration complete response letter noting certain deficiencies related to Alvotech’s manufacturing facility in Reykjavik, Iceland.
“Satisfactory resolution of the deficiencies is required before the FDA may approve this biologics license application,” Alvotech noted, with the agency’s findings