Alvotech resubmits FDA BLAs for golimumab and aflibercept biosimilars
Alvotech has resubmitted Biologics License Applications (BLAs) to the US Food and Drug Administration for two biosimilar candidates: AVT05, a proposed biosimilar to golimumab (Simponi and Simponi Aria), and AVT06, a proposed biosimilar to aflibercept 2 mg (Eylea). The Iceland-headquartered company said it anticipates a standard six-month FDA review period for both submissions.
The resubmissions follow a Post-Application Action Letter (PAAL) the FDA had issued in relation to Alvotech's Reykjavik manufacturing facility, as well as observations arising from a routine current Good Manufacturing Practice (cGMP) surveillance inspection completed at that site in May 2026. The company said it has responded to both sets of agency feedback and has continued to strengthen its quality systems as part of an ongoing enhancement programme.
Manufacturing backdrop
Chief executive Lisa Graver said the resubmissions mark "an important milestone following extensive work across our manufacturing and quality organisation," adding that the outcome of the May inspection demonstrated "the strong cGMP fundamentals of the site and the robustness of the improvements implemented since last year." The company has been working to resolve manufacturing-related queries that had previously delayed these applications, and the resubmissions indicate that Alvotech believes it has now addressed those concerns to a sufficient standard to restart the regulatory clock.
Both products are already approved and marketed in several jurisdictions. AVT05 holds approvals in the European Economic Area, the UK, and Japan; AVT06 is approved in the EEA, UK, Japan, and Canada. Commercial responsibility for the US market rests with Teva Pharmaceutical Industries under a development and commercialisation partnership, with Alvotech retaining responsibility for manufacturing and development.
Market context
The US biosimilar market for immunology and ophthalmology biologics is expanding rapidly but remains intensely competitive. Golimumab, marketed by Johnson & Johnson, is a TNF-blocker used across rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, ulcerative colitis, and polyarticular juvenile idiopathic arthritis — an indication set that attracts multiple biosimilar developers. In the aflibercept space, Regeneron's Eylea has faced a growing roster of approved and pipeline rivals since biosimilar entry began in 2024, with pricing pressure intensifying across the anti-VEGF retinal category.
For Alvotech, US approval of AVT05 and AVT06 would meaningfully broaden its commercial footprint beyond its adalimumab (Humira) biosimilar, which launched in the US through its Teva partnership. The company also has a denosumab biosimilar, AVT03, under US regulatory review via a separate arrangement with Dr. Reddy's Laboratories. Together, these three submissions represent a significant portion of the high-value reference biologic market.
Regulatory path
The six-month review timeline, if the FDA accepts the resubmissions without further queries, would place potential action dates in the final quarter of 2026 or early 2027. Investors will be watching for any further correspondence from the agency, particularly given the manufacturing-related history of these dossiers. A Complete Response Letter or additional inspection activity would push timelines out and weigh on the stock. Equally, a clean review and approval decision for one or both products would validate the remediation work undertaken at the Reykjavik facility and open the US market for what are already commercially active products in major ex-US jurisdictions.