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

• The intravenous (IV) formulation of AVTOZMA^® (tocilizumab-anoh) is expected to be available in the U.S. in August 2025
• Approval was received for multiple indications, including rheumatoid arthritis (RA), giant cell arteritis (GCA), polyarticular juvenile idiopathic arthritis (pJIA), systemic juvenile idiopathic arthritis (sJIA) and COVID-19^[1]
• AVTOZMA^® becomes Celltrion's fifth immunology biologic and seventh biosimilar approved by the FDA

JERSEY CITY, N.J., Jan. 30, 2025 /PRNewswire/ -- Celltrion today announced that the U.S. Food and Drug Administration (FDA) has approved AVTOZMA^® (CT-P47, tocilizumab-anoh) in both an intravenous (IV) and subcutaneous (SC) formulation as a biosimilar to ACTEMRA^®. AVTOZMA is indicated for the treatment of multiple diseases including rheumatoid arthritis (RA), giant cell arteritis (GCA), polyarticular juvenile idiopathic arthritis (pJIA), systemic juvenile idiopathic arthritis (sJIA) and coronavirus disease (COVID-19).^[1]

"Introducing both IV and SC formulations of AVTOZMA provides flexibility and a wider range of treatment options," said Thomas Nusbickel, Chief Commercial Officer at Celltrion USA. "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."

The FDA's decision is based on a comprehensive data package and the totality of evidence, including the results from a phase III study 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 clinical results demonstrated that AVTOZMA and its reference tocilizumab are highly similar and have no clinically meaningful differences in terms of efficacy, safety, pharmacokinetics (PK) and immunogenicity.^[2]

In accordance with the patent settlement agreement with Genentech, the intravenous (IV) formulation of AVTOZMA^® (tocilizumab-anoh) is expected to be available in the U.S. in August 2025. Celltrion has a license to market the subcutaneous formulation in the U.S. commencing on the license date, which remains confidential.

AVTOZMA is Celltrion's seventh biosimilar granted marketing authorization in the U.S.

About AVTOZMA^® (tocilizumab-anoh)^[1] 

AVTOZMA^® (tocilizumab-anoh), containing the active ingredient tocilizumab, is a recombinant humanized monoclonal antibody that acts as an interleukin 6 (IL-6) receptor antagonist. Based on data from the global Phase III clinical trial designed to evaluate the efficacy, pharmacokinetics (PK), safety, and immunogenicity of CT-P47 compared to reference tocilizumab, AVTOZMA was filed for regulatory approval with the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) in January and February 2024, respectively.  

INDICATION 

AVTOZMA^® (tocilizumab-anoh) is an interleukin-6 (IL-6) receptor antagonist indicated for treatment of:

• Rheumatoid Arthritis (RA): Adult patients with moderately to severely active RA who have had an inadequate response to one or more Disease-Modifying Anti-Rheumatic Drugs (DMARDs).
• Giant Cell Arteritis (GCA): Adult patients with GCA.
• Polyarticular Juvenile Idiopathic Arthritis (pJIA): Patients 2+ years-old with active pJIA.
• Systemic Juvenile Idiopathic Arthritis (sJIA): Patients 2+ years-old with active sJIA.
• COVID-19: Hospitalized adult patients with COVID-19 who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).

IMPORTANT SAFETY INFORMATION

WARNING: RISK OF SERIOUS INFECTIONS

AVTOZMA^® and other tocilizumab products may increase the risk of serious infections, potentially leading to hospitalization or death, especially in patients using concurrent immunosuppressants.

If a serious infection develops, interrupt AVTOZMA until the infection is controlled. Reported infections include:

• Active tuberculosis (TB) which may present with pulmonary or extrapulmonary disease. Test for latent TB before and during treatment (except in COVID-19 patients) and treat latent infections before starting AVTOZMA.
• Invasive fungal infections: Such as candidiasis, aspergillosis, and pneumocystis, may present as disseminated rather than localized disease.
• Opportunistic infections, including bacterial, viral and other opportunistic pathogens.

Monitor patients for signs of infection, including TB, during and after AVTOZMA treatment.
Contraindications: Known hypersensitivity to tocilizumab products.
Serious Infections. Serious and sometimes fatal infections have been reported with AVTOZMA. Do not use during active infections, including localized infections. Discontinue AVTOZMA if a serious infection occurs and resume only once controlled.

Gastrointestinal (GI) Perforation. Gastrointestinal perforations, often linked to diverticulitis, have been reported with tocilizumab. Use AVTOZMA cautiously in high-risk patients and promptly evaluate new abdominal symptoms for early detection and management.

Hepatoxicity. Monitor for hepatic injury signs. Avoid AVTOZMA if ALT/ AST >1.5x ULN (RA/GCA) or >10x ULN (COVID-19); discontinue if ALT/AST >5x ULN or symptoms of liver disease develop.

Changes in Laboratory Parameters. Monitor neutrophils, platelets, liver enzymes, and lipids due to potential treatment-related changes; avoid initiating AVTOZMA in patients with critically low ANC or platelet counts.

Immunosuppression. The impact of AVTOZMA on malignancy development is unknown, but it may increase risk as an immunosuppressant.

Hypersensitivity Reactions, including anaphylaxis, and death, have occurred; administer IV infusions with anaphylaxis management support, discontinue permanently if reactions occur, and avoid use in patients with known hypersensitivity.

Demyelinating Disorders. The impact of tocilizumab on demyelinating disorders is unknown, but rare cases were reported; monitor symptoms and use caution with preexisting or recent disorders.

Active Hepatic Disease and Hepatic Impairment. Treatment with AVTOZMA is not recommended.

Live Vaccines. Avoid concurrent use with AVTOZMA.

Adverse Reactions (≥5%) include upper respiratory tract infections, nasopharyngitis, headache, hypertension, elevated ALT, and injection site reactions.

For more information, see Full Prescribing Information.

About Celltrion

Celltrion is a leading biopharmaceutical company based in Incheon, South Korea that specializes in researching, developing, manufacturing, marketing and sales of innovative therapeutics that improve people's lives worldwide. Celltrion endeavors to offer high-quality, cost-effective solutions through an extensive global network that spans more than 110 countries. Celltrion has seven biosimilars approved by the U.S. FDA: INFLECTRA^® (infliximab-dyyb), TRUXIMA^® (rituximab-abbs), HERZUMA^® (trastuzumab-pkrb), VEGZELMA^® (bevacizumab-adcd), YUFLYMA^®(adalimumab-aaty), STEQEYMA^® (ustekinumab-stba), and AVTOZMA^® (tocilizumab-anoh), as well as novel biologic ZYMFENTRA^® (infliximab-dyyb). For more information, please visit https://www.celltrion.com/en-us.

FORWARD-LOOKING STATEMENT

Certain information set forth in this press release contains statements related to our future business and financial performance and future events or developments involving Celltrion Inc. and its subsidiaries that may constitute forward-looking statements, under pertinent securities laws. This press release contains forward looking statements. These statements may be also identified by words such as "prepares," "hopes to," "upcoming," "plans to," "aims to," "to be launched," "is preparing," "once gained," "could," "with the aim of," "may," "once identified," "will," "working towards," "is due," "become available," "has potential to," the negative of these words or such other variations thereon or comparable terminology.

In addition, our representatives may make oral forward-looking statements. Such statements are based on the current expectations and certain assumptions of Celltrion Inc. and its subsidiaries' management, of which many are beyond its control.

Forward-looking statements are provided to allow potential investors the opportunity to understand management's beliefs and opinions in respect of the future so that they may use such beliefs and opinions as one factor in evaluating an investment. These statements are not guarantees of future performance and undue reliance should not be placed on them.

Such forward-looking statements necessarily involve known and unknown risks and uncertainties associated with the company's business, including the risk factors disclosed in its Annual Report and/or Quarterly Reports, which may cause actual performance and financial results in future periods to differ materially from any projections of future performance or results expressed or implied by such statements.

Celltrion Inc. and its subsidiaries undertake no obligation to update forward-looking statements if circumstances or management's estimates or opinions should change except as required by applicable securities laws.

Trademarks

AVTOZMA^® is a registered trademark of Celltrion Inc.
ACTEMRA^® is a registered trademark of Chugai Pharmaceutical Co., Ltd. 

References

[1] AVTOZMA U.S. prescribing information (2024)
[2] Gerd Burmester et al., Similar Efficacy, PK, Safety, and Immunogenicity of Tocilizumab Biosimilar (CT-P47) and Reference Tocilizumab in Patients with Moderate-to-Severe Active Rheumatoid Arthritis: Week 52 Results from the Phase III Single Transition Study. Poster Presentation (abstract no. 0502). Presented at ACR 2024. Available at: https://acrabstracts.org/abstract/similar-efficacy-pk-safety-and-immunogenicity-of-tocilizumab-biosimilar-ct-p47-and-reference-tocilizumab-in-patients-with-moderate-to-severe-active-rheumatoid-arthritis-week-52-results-from-the/ [Last accessed December 2024]

For further information please contact: 
Andria Arena
[email protected]
+1 516-578-0057

SOURCE Celltrion