0001171843-26-003911
SEC filingAlvotech resubmitted U.S. BLAs for AVT05 and AVT06 to the FDA, with a six-month review expected, and announced approval of all resolutions at its 2026 Annual General Meeting.
This 6-K filing contains two significant disclosures. First, Alvotech resubmitted Biologics License Applications (BLAs) for AVT05, a proposed biosimilar to Simponi/Simponi Aria (golimumab), and AVT06, a proposed biosimilar to Eylea (aflibercept) 2 mg, to the U.S. FDA. These resubmissions follow the company's response to a Post-Application Action Letter (PAAL) regarding its Reykjavik manufacturing facility, as well as responses to observations from a routine cGMP surveillance inspection completed in May 2026. Management expressed confidence in the facility's improvements and expects a six-month review timeline, consistent with standard FDA procedures. Successful approval would add to Alvotech's biosimilar portfolio and strengthen its partnership with Teva, which handles U.S. commercialization. Second, the company held its 2026 Annual and Extraordinary General Meeting on June 3, 2026, where all proposed resolutions were approved. Detailed meeting minutes and voting results are available on the company's investor portal. These developments highlight Alvotech's progress in addressing regulatory hurdles and maintaining corporate governance standards.