FDA Accepts BLA for Golimumab Biosimilar for Inflammatory Conditions

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The FDA has accepted Alvotech and Teva’s biologics license applications (BLA) for AVT05, a proposed biosimilar to golimumab (Simponi and Simponi Aria) for treating inflammatory conditions including rheumatoid arthritis (RA), psoriatic arthritis (PsA), ankylosing spondylitis (AS), and ulcerative colitis (UC).¹

"This is a significant step towards being able to offer U.S. patients access to biosimilar golimumab," Joseph McClellan, Chief Scientific Officer, Alvotech, said in a statement.¹ “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."

The FDA expects to complete the review process for the BLAs in the fourth quarter of 2025. The BLA submissions are based off of positive top-line results from a confirmatory clinical study comparing efficacy, safety, and immunogenicity between AVT05 and reference golimumab in patients with moderate to severe rheumatoid arthritis. Another previous pharmacokinetic study demonstrated comparable pharmacokinetics, safety, and tolerability of AVT05 compared to and reference golimumab in healthy adult participants, data from which was announced in November 2023.

“Biosimilars are ushering a new treatment paradigm and have become an integral staple in the healthcare ecosystem. 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,” Thomas Rainey, Senior Vice President, U.S. Biosimilars at Teva, added to the statement.¹

Another biosimilar for inflammatory and rheumatological conditions, Celltrion’s tocilizumab-anoh biosimilar (CT-P47), was just FDA approved under the name Avtozmain both an intravenous (IV) and subcutaneous (SC) formulation for treating rheumatological diseases including RA, giant cell arteritis (GCA), polyarticular juvenile idiopathic arthritis (pJIA), and systemic juvenile idiopathic arthritis (sJIA), as well as coronavirus disease (COVID-19).²

"Introducing both IV and SC formulations of AVTOZMA provides flexibility and a wider range of treatment options," Thomas Nusbickel, Chief Commercial Officer at Celltrion USA said in a statement.² "This approval represents a strategic addition to our immunology portfolio, further strengthening our commitment to delivering accessible and high-quality treatment options for patients and healthcare providers. Our goal is to provide safe and effective alternatives and ensure appropriate access so plan sponsors can address unique population needs."

Tocilizumab-anoh will be available in its IV formulation as 80 mg/4 mL (20 mg/mL), 200 mg/10 mL (20 mg/mL), 400 mg/20 mL (20 mg/mL) and in its SC formulation in 162 mg/0.9 mL in a single-dose prefilled syringe or single-dose autoinjector.²

The approval was based on data from a phase 3 study demonstrating biosimilarity between AVTOZMA and reference tocilizumab in patients with moderate to severe active RA. The study’s primary endpoint, change from baseline in disease activity score using 28 joints (DAS28)-ESR, was met at Week 24. The final 1-year results also supported comparability in secondary efficacy, pharmacokinetic (PK), safety and immunogenicity between tocilizumab-anoh and reference tocilizumab.²

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). News release. Alvotech. January 27, 2025. https://www.globenewswire.com/news-release/2025/01/27/3015410/0/en/Alvotech-and-Teva-Announce-Filing-Acceptance-of-U-S-Biologics-License-Applications-for-AVT05-a-Proposed-Biosimilar-to-Simponi-and-Simponi-Aria-golimumab.html

2. U.S. FDA approves Celltrion's AVTOZMA® (tocilizumab-anoh), a biosimilar to ACTEMRA®. News release. Celltrion. January 31, 2025. https://www.celltrion.com/en-us/company/media-center/press-release/3668