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

Core Insights - Alvotech received a complete response letter (CRL) from the FDA regarding its Biologics License Application (BLA) for AVT05, a biosimilar to Simponi® (golimumab) [1][2] - The CRL indicated 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 revenue outlook for 2025 has been adjusted to $570-$600 million, with adjusted EBITDA expected to be $130-$150 million, reflecting a decrease due to ongoing investments to address facility issues [5] Company Overview - Alvotech is a biotech company focused on developing and manufacturing biosimilar medicines globally, aiming to be a leader in the biosimilar market [6] - The company has a pipeline of eight disclosed biosimilar candidates targeting various conditions, including autoimmune disorders and cancer [6] - Alvotech has established strategic commercial partnerships across multiple regions, including the U.S., Europe, and Asia, to enhance its market reach [6]