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FDA Approves Tocilizumab-Anoh as a Biosimilar to Actemra
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Key Takeaways
- Tocilizumab-anoh (Avtozma) is approved for intravenous and subcutaneous administration for multiple diseases, including rheumatoid arthritis and COVID-19.
- The FDA's approval is based on comprehensive data and evidence, including a phase 3 study.
The approval includes indications for rheumatoid arthritis, giant cell arteritis, polyarticular juvenile idiopathic arthritis, systemic juvenile idiopathic arthritis, and COVID-19.
This is an ongoing story.
The FDA approved tocilizumab-anoh (Avtozma; Celltrion), a biosimilar to tocilizumab (Actemra; Genentech), as both an intravenous and subcutaneous formulation to treat multiple diseases, including rheumatoid arthritis (RA), giant cell arteritis, polyarticular juvenile idiopathic arthritis, systemic juvenile idiopathic arthritis, and COVID-19.
The drug is indicated for imultiple diseases, such as rheumatoid arthritis (RA), giant cell arteritis, polyarticular juvenile idiopathic arthritis, systemic juvenile idiopathic arthritis, and COVID-19.| Pawel | stock.adobe.com
The approval is based on comprehensive data and totality of evidence, which included a phase 3 study demonstrating the biosimilarity between the biosimilar and the reference product for patients with moderate to severe active RA. In the study, investigators aimed to compare the efficacy and safety of the biosimilar to the reference product when co-administered with methotrexate. Patients were included if they were aged 18 to 75 years old with an RA diagnosis according to the 2010 American College of Rheumatology/European League Against Rheumatism classification criteria for at least 24 weeks prior to administration of the study drug.1,2
The study included 22 centers in Poland and included 3 periods: screening, treatment, and end of study. Treatment was randomized on day 1 to either the biosimilar or the European Union formulation of the reference product every 4 weeks until week 20. In the second treatment point, patients who were on the biosimilar continued with it every 4 weeks to week 48, and investigators re-assigned treatment for the reference product group to either continuing the reference product or switch to the biosimilar every 3 weeks until week 48. The primary end points included mean change from baseline in Disease Activity Score-28 for Rheumatoid Arthritis with ESR (DAS28-ESR) at week 12 and at week 24. Additional end points included change from baseline in ESR, CRP, Simplified Disease Activity Index, and Clinical Disease Activity.3
In the first treatment period, there was a total of 471 patients, with 234 receiving the biosimilar and 237 receiving the 237. Of these patients, 9 and 18 discontinued the study drugs, respectively. In the second treatment period, there were 444 patients, with 225 continuing with the biosimilar, 109 continuing with the reference product, and 110 switching to the biosimilar. There were 8, 3, and 2 patients, respectively, who discontinued study treatment. Investigators found that the treatment met the primary end points for least-square mean change from baseline for DAS28-ESR at weeks 12 and 24. Further, there were improvements for all secondary end points and were similar between both the biosimilar and the reference product.3
Celltrion submitted the biologics license application for the biosimilar in February 2024. Tocilizumab is an IL-6 receptor antagonist that binds to the soluable and membrane IL-6 receptors. It has the ability to inhibit IL-6-mediated signaling, which is related to inflammation.4
Tocilizumab-anoh will be available in both formulations and dosages as the reference product.1
