Late Wednesday, The FDA Issued A Complete Response Letter To Alvotech's Second Application For AVT02, A Biosimilar Candidate For Humira (Adalimumab); The Letter Noted Certain Deficiencies Regarding The Reinspection Of Its Reykjavik Facility
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The FDA has issued a complete response letter to Alvotech's second application for AVT02, a biosimilar candidate for Humira. The letter noted deficiencies regarding the reinspection of its Reykjavik facility. This application contained data to support approval as a high-concentration biosimilar and additional information to support the interchangeability designation.
June 29, 2023 | 8:38 am
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Alvotech's second application for AVT02, a biosimilar candidate for Humira, has been responded to by the FDA, citing deficiencies in the reinspection of its Reykjavik facility.
The FDA's response letter to Alvotech's second application for AVT02, a biosimilar candidate for Humira, cites deficiencies in the reinspection of its Reykjavik facility. This could potentially delay the approval process for AVT02, negatively impacting Alvotech's stock in the short term.
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