> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# FDA Accepts BLA for Alvotech’s Simponi BLA
- URL: https://www.fdaweb.com/fda-accepts-bla-for-alvotechs-simponi-bla/
- Published: 2025-01-29T12:00:00.000Z
- Updated: 2026-09-14T14:51:55.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5158571

FDA has accepted for review an Alvotech and Teva Pharmaceuticals BLA for AVT05, Alvotech’s proposed biosimilar to Janssen Biotech’s Simponi and Simponi Aria (golimumab), which are used to treat moderate to severe inflammatory conditions, including rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, and ulcerative colitis. An FDA action is expected in fourth quarter, the companies say.

Last year, Alvotech announced positive top-line results from a confirmatory clinical study comparing efficacy, safety, and immunogenicity between AVT05 and Simponi in patients with moderate to severe rheumatoid arthritis. In 2023, Alvotech announced positive topline results from a pharmacokinetic study, which assessed the pharmacokinetics, safety, and tolerability of AVT05 compared to Simponi in healthy adult participants.

Alvotech and Teva say they entered into a strategic partnership in 2020 to develop and commercialize five of Alvotech’s biosimilar product candidates, including AVT05\. The partnership has since expanded and now includes nine products in total. Alvotech focuses on development and manufacturing using its purpose-built end-to-end platform, while Teva is responsible for commercialization in the U.S., they say.

To date, two biosimilars developed under the partnership have been approved. In 2/2024, FDA approved Simlandi (adalimumab-ryvk), the first high-concentration, citrate-free interchangeable biosimilar to Humira (adalimumab). Simlandi was launched in the U.S. in May 2024\. In 4/2024, the agency approved Selarsdi (ustekinumab-aekn) as a biosimilar to Stelara (ustekinumab).