Alvotech resubmits AVT05, AVT06 BLAs

Alvogen>>>, a biotechnology company, announced the resubmission of Biologics License Applications (BLAs) for AVT05 (a biosimilar to Simponi and Simponi Aria) and AVT06 (a biosimilar to Eylea) to the United States — Food and Drug Administration>>> (FDA). This action follows Alvogen>>>'s response to a Post-Application Action Letter and observations from a routine cGMP surveillance FDA inspection at its Reykjavik manufacturing facility in May 2026. Alvogen>>> expects the United States — Food and Drug Administration>>> (FDA) to complete a six-month review of these applications. Sun Pharma>>> is partnered with Alvogen>>> for the commercialization of AVT05 and AVT06 in the United States>>>. These biosimilars have already received approvals in other markets such as the European Economic Area>>>, the United Kingdom>>>, Japan>>>, and Canada>>>.