U.S. FDA Approves Celltrion's AVTOZMA® (tocilizumab-anoh), a Biosimilar to ACTEMRA®

The U.S. Food and Drug Administration (FDA) has approved Celltrion's AVTOZMA® (tocilizumab-anoh), a biosimilar to Roche's ACTEMRA® (tocilizumab), for the treatment of various autoimmune and inflammatory diseases. This approval expands patient access to a lower-cost alternative to the reference drug and intensifies competition in the U.S. market for tocilizumab.

AVTOZMA is indicated for the treatment of moderate to severely active rheumatoid arthritis (RA), active systemic juvenile idiopathic arthritis (sJIA), polyarticular juvenile idiopathic arthritis (pJIA), giant cell arteritis (GCA), and hospitalized adult patients with COVID-19 who require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). The drug is available in both intravenous (IV) and subcutaneous (SC) formulations, offering patients and healthcare providers flexibility in administration.

Celltrion's approval of AVTOZMA comes after a comprehensive data package, including results from a Phase III clinical trial demonstrating biosimilarity between AVTOZMA and reference tocilizumab in patients with moderate to severe active RA. The primary endpoint was met in terms of change from baseline in disease activity score using 28 joints (DAS28)-ESR at Week 24, and the final 1-year results supported comparability in secondary efficacy, pharmacokinetic (PK), safety, and immunogenicity results between AVTOZMA and reference tocilizumab.

The approval of AVTOZMA is expected to have a significant impact on the U.S. market for tocilizumab, where Roche's drug generated $1.4 billion in sales in H1 2023. With multiple biosimilars now approved, including Biogen's Tofidence and Fresenius Kabi's biosimilar, competition in the market is set to intensify, potentially leading to lower prices and increased patient access to tocilizumab.



Celltrion's success in securing a prescription list agreement with a major PBM before the launch of Aaty, its biosimilar to Humira, demonstrates the potential for increased market penetration of biosimilars. This strategy could also apply to AVTOZMA, leading to greater access for patients and healthcare systems.

The approval of AVTOZMA is a significant milestone for Celltrion, further solidifying its position as a leader in the global biosimilars market. The company's vertically integrated model ensures supply chain stability while addressing the specific challenges faced by U.S. healthcare professionals and patients. This approval underscores Celltrion's commitment to supporting U.S. healthcare systems by improving access to high-quality, affordable treatments.

In conclusion, the approval of AVTOZMA by the FDA is a significant development in the U.S. market for tocilizumab, offering patients and healthcare systems a lower-cost alternative to the reference drug. With multiple biosimilars now approved, competition in the market is set to intensify, potentially leading to lower prices and increased patient access to tocilizumab. Celltrion's success in securing prescription list agreements and its vertically integrated model position the company well to capitalize on this growing market opportunity.