Alvotech resubmits FDA applications for Simponi and Eylea biosimilars

Alvotech (NASDAQ:ALVO) has officially resubmitted its Biologics License Applications (BLAs) to the U.S. Food and Drug Administration (FDA) for two of its lead biosimilar candidates: AVT05, a proposed biosimilar to Simponi and Simponi Aria (golimumab), and AVT06, a proposed biosimilar to Eylea (aflibercept) 2 mg.

The resubmissions follow an intensive period of facility upgrades at the company’s Reykjavik, Iceland, manufacturing site.

In May 2026, the FDA concluded a routine current Good Manufacturing Practice (cGMP) surveillance inspection at the facility, which resulted in the issuance of a Form 483.

Alvotech has since addressed these observations and integrated the necessary enhancements to satisfy federal regulatory requirements, positioning the site to support the firm’s broader U.S. commercial ambitions.

The company anticipates a standard six-month review period for these applications.

The resubmission marks a significant recovery effort, particularly for AVT05, which previously received a Complete Response Letter (CRL) from the FDA in late 2025 related to pre-licensing inspection observations.

By successfully closing out these findings, the company aims to move past previous operational delays and bring its pipeline, which it identifies as a key driver for 2027 growth, closer to market entry.

The proposed biosimilars are central to Alvotech’s strategy of expanding its U.S. market presence.

AVT05 is designed to offer a cost-effective alternative to the reference products for the treatment of autoimmune diseases such as rheumatoid arthritis and ulcerative colitis.

AVT06, targeting the widely-used ocular therapeutic Eylea, represents a significant addition to the firm’s ophthalmology portfolio.