FDA Accepts Review of Golimumab Biosimilar
Known as AVT05, the Alvotech medication is a proposed biosimilar to Simponi, prescribed to treat various inflammatory conditions.
The FDA is set to review the Biologics License Applications (BLAs) for Alvotech’s AVT05, a proposed biosimilar to Simponi and Simponi Aria, branded forms of golimumab, which is a medication prescribed to treat a multitude of inflammatory conditions, such as ankylosing spondylitis, rheumatoid arthritis, and psoriatic arthritis.1 These represent the first BLA filing acceptances announced for a biosimilar candidate to golimumab in the United States.
The FDA’s review process is expected to have a Q4 2025 completion date.
"This is a significant step towards being able to offer US patients access to biosimilar golimumab," said Joseph McClellan, chief scientific officer of Alvotech. “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."
Back in August 2020, Alvotech and Teva Pharmaceuticals entered into a strategic partnership involving the exclusive commercialization of five of Alvotech’s biosimilar product candidates; AVT05 is one of those five. Over the past four-and-a-half years, this portfolio has grown to nine products. The workflow involves Alvotech being responsible for the development and manufacturing; Teva would handle US commercialization efforts.
“Biosimilars are ushering a new treatment paradigm and have become an integral staple in the healthcare ecosystem,” explained Thomas Rainey, Tevan’s senior vice president of US biosimilars. “Teva’s strategic partnership with Alvotech underscores our commitment to continue to bring cost-saving options to more patients and deliver better outcomes for those with inflammatory conditions.”
Further, ever since the parties entered into a strategic partnership, two biosimilars have been approved by the FDA approval. This includes Simlandi (adalimumab-ryvk), a high-concentration, citrate-free interchangeable biosimilar to Humira (adalimumab) in February 2024 and In Selarsdi (ustekinumab-aekn) as a biosimilar to Stelara (ustekinumab) in April 2024.
Also during that April 2024 timeframe, Alvotech revealed positive top-line results from a randomized, double-blind, 2-arm, multicenter confirmatory clinical study2 that compared efficacy, safety, and immunogenicity between AVT05 and Simponi in patients with moderate to severe rheumatoid arthritis. And, in November 2023, positive topline results from a pharmacokinetic study which assessed the pharmacokinetics, safety, and tolerability of AVT05 compared to Simponi in healthy adult participants.3
“These results demonstrate the strength of our platform approach to biosimilars development and manufacture, combining a well-designed and executed clinical study with the design of a high-quality manufacturing process and strong analytical capabilities,” added McClellan. “As we progress more biosimilar candidates through clinical development and approval, we continue to reaffirm our commitment to improving patient lives by expanding access to affordable biologics.”
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. January 27, 2025. Accessed January 27, 2025. https://investors.alvotech.com/news-releases/news-release-details/alvotech-and-teva-announce-filing-acceptance-us-biologics
2. Alvotech Announces Topline Results from a Confirmatory Clinical Study for AVT05, a Proposed Biosimilar for Simponi® (golimumab). Alvotech. April 24, 2024. Accessed January 27, 2025. https://investors.alvotech.com/news-releases/news-release-details/alvotech-announces-topline-results-confirmatory-clinical-study
3. Alvotech Announces Positive Top-Line Results from a Pharmacokinetic Study for AVT05, a Proposed Biosimilar for Simponi® and Simponi Aria). Alvotech. November 29, 2023. Accessed January 27, 2025. https://investors.alvotech.com/news-releases/news-release-details/alvotech-announces-positive-top-line-results-pharmacokinetic
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