Alvotech Provides Update on the Status of U.S. Biologics License Application for AVT05

Core Points - Alvotech announced that the FDA issued a complete response letter (CRL) for its Biologics License Application (BLA) for AVT05, a biosimilar candidate to Simponi® (golimumab) [1][2] - The CRL highlighted deficiencies identified during the FDA's pre-license inspection of Alvotech's Reykjavik manufacturing facility, which must be resolved before approval [2] - Alvotech's total revenues for 2025 are now expected to be between $570 million and $600 million, with adjusted EBITDA projected at $130 million to $150 million, reflecting a downward revision due to ongoing investments to address facility issues [5] Company Overview - Alvotech is a global biotech company focused on developing and manufacturing biosimilar medicines, aiming to be a leader in the biosimilar space with a pipeline that includes eight disclosed biosimilar candidates targeting various diseases [6] - The company has established a network of strategic commercial partnerships across multiple regions, including the U.S., Europe, and Asia, to enhance its market reach and leverage local expertise [6]