FDA Accepts Review of Biologics License Application for AVT05, a Biosimilar Candidate for Golimumab

The FDA accepted a biologics license application (BLA) for review, seeking the approval of AVT05 (Alvotech, Teva Pharmaceuticals), a proposed biosimilar candidate for golimumab (Simponi and Simponi Aria; Janssen Biotech Inc), to treat multiple inflammatory conditions. This marks the first US BLA filing acceptance for a biosimilar candidate to golimumab, with an anticipated FDA review in the fourth quarter of 2025, according to the study authors.¹

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"This is a significant step towards being able to offer US patients access to biosimilar golimumab," Joseph McClellan, chief scientific officer of Alvotech, said in a news release. “Our in-house capability allowing us to match the cell line and process used to manufacture the reference biologic, has given us an important head start in developing a biosimilar candidate to Simponi and Simponi Aria for global markets."¹

AVT05 is an investigational product that has not received regulatory approval in any country and serves as a biosimilar candidate for golimumab, a monoclonal antibody that inhibits tumor necrosis factor alpha (TNF alpha). Researchers have found a link between elevated TNF alpha levels with the pathophysiology of chronic inflammatory diseases, including rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis.¹ Golimumab is indicated to treat the highlighted conditions, along with ulcerative colitis through its role in targeting and blocking TNF alpha to reduce inflammation and other additional symptoms.²

AVT05 has been assessed in 2 clinical trials that evaluated the safety and efficacy of the biosimilar candidate compared to golimumab.¹

In April 2024, the company shared positive topline results from the randomized, double-blind, 2-arm, multicenter AVT05-GL-C01 confirmatory clinical study (NCT05842213) that assessed the efficacy, safety, and immunogenicity between subcutaneous AVT05 and golimumab among individuals with moderate to severe rheumatoid arthritis. The study met its primary endpoint in change from baseline to week 16, measured by the Disease Activity Score-28 (das28-crp) for rheumatoid arthritis, demonstrating therapeutic comparability between AVT05 and golimumab, according to study authors.³

Alvotech also shared positive results from the pharmacokinetic study (NCT05632211) that assessed the pharmacokinetics, safety, and tolerability of AVT05 compared to golimumab in November 2023. This study included a total of 336 healthy individuals that administered a single dose of 50 mg/0.5 mL pre-filled syringe, through subcutaneous injection— meeting the primary endpoints of the study.³

If approved, the drug would be added to the company's portfolio, which includes adalimumab-ryvk (Simlandia; Alcotech, Teva Pharmaceuticals), an interchangeable biosimilar for adalimumab (Humira; AbbVie) receiving FDA approval in February 2024.⁴ Additionally, ustekinumab-aekn (Selarsdi; Teva Pharmaceuticals, Alvotech) an injection for subcutaneous use as a biosimilar to ustekinumab (Stelara; Janssen Immunology) received FDA approval in April 2024.⁵

“Biosimilars are ushering a new treatment paradigm and have become an integral staple in the healthcare ecosystem,” said Thomas Rainey, senior vice president, US Biosimilars at Teva, in a news release.¹

REFERENCES

1. Alvotech and Teva Announce Filing Acceptance of U.S. Biologics License Applications for AVT05, a Proposed Biosimilar to Simponi® and Simponi Aria® (golimumab). Alvotech. News release. January 27, 2025. Accessed January 28, 2025. https://investors.alvotech.com/news-releases/news-release-details/alvotech-and-teva-announce-filing-acceptance-us-biologics

2. Golimumab (intravenous route, subcutaneous route). Mayo Clinic. News release. May 1, 2024. Accessed January 28, 2025. https://www.mayoclinic.org/drugs-supplements/golimumab-intravenous-route-subcutaneous-route/description/drg-20073012

3. Alvotech Announces Topline Results from a Confirmatory Clinical Study for AVT05, a Proposed Biosimilar for Simponi® (golimumab). Alvotech. News release. April 24, 2024. Accessed January 28, 2025. https://investors.alvotech.com/news-releases/news-release-details/alvotech-announces-topline-results-confirmatory-clinical-study

4. Gallagher A. FDA Approves Adalimumab-ryvk as Interchangeable Biosimilar for Humira. Pharmacy Times. News release. February 26, 2024. Accessed January 28, 2025. https://www.pharmacytimes.com/view/fda-approves-adalimumab-ryvk-as-interchangeable-biosimilar-for-humira

5. Gallagher A. FDA Approves Ustekinumab Biosimilar to Stelara for Treatment of Plaque Psoriasis. Pharmacy Times. News release. April 17, 2024. Accessed January 28, 2025. https://www.pharmacytimes.com/view/fda-approves-ustekinumab-biosimilar-to-stelara-for-treatment-of-plaque-psoriasis