Celltrion Healthcare Presents Positive One-Year Data for the First High-Concentration, Low-Volume and Citrate-Free Biosimilar Adalimumab, YuflymaTM (CT-P17) in Patients With Rheumatoid Arthritis at EULAR 2021

• One-year data have shown equivalent efficacy and comparable safety for Yuflyma� (CT-P17) against reference adalimumab in patients with moderate-to-severe active rheumatoid arthritis (RA)
• Sustained and comparable efficacy in terms of ACR20/50/70 response rates was achieved in patients receiving maintenance therapy (CT-P17 or reference-adalimumab) and also in patients switched at week 26 from reference-adalimumab to CT-P17 up to one year
• Celltrion Healthcare has also received marketing authorisation for its subcutaneous formulation of infliximab, Remsima^® SC, for direct use of subcutaneous therapy without IV loading in adults with RA

INCHEON, South Korea–(BUSINESS WIRE)–Celltrion Healthcare today presented positive results from the Phase III CT-P17 3.1 trial comparing the efficacy and safety of biosimilar adalimumab, Yuflyma™, with reference adalimumab in patients with active rheumatoid arthritis (RA) at the Annual European Congress of Rheumatology 2021 (EULAR Virtual Congress 2021). The trial met its primary and secondary endpoints, demonstrating that the efficacy, pharmacokinetics (PK), safety and immunogenicity of CT-P17, a high-concentration (100mg/mL), low-volume and citrate-free adalimumab biosimilar, is comparable to reference adalimumab in the treatment of patients with moderate-to-severe active RA up to one year. The abstract has been published in an official supplement of the Annals of Rheumatic Diseases (ARD).¹

The randomised, double-blind, Phase III study has demonstrated therapeutic equivalence of CT-P17 to reference adalimumab in 648 patients with active moderate-to-severe RA, despite methotrexate treatment, who were randomised (1:1) to receive either 40mg of CT-P17 or reference adalimumab every two weeks up to week 24.² Prior to dosing at week 26, 608 patients were randomised again to either maintaining their treatment or being switched from reference adalimumab to CT-P17. After the second randomisation, 303 patients continued with CT-P17, 153 patients continued with reference adalimumab and 151 patients were switched from reference adalimumab to CT-P17 up to week 48.

Results demonstrated comparable efficacy in terms of ACR20/50/70 response rates, both in patients receiving maintenance therapy and in patients switched from reference adalimumab to CT-P17 up to week 52. With respect to PK, mean Ctrough levels were maintained after week 24 in all three treatment groups with the observed mean Ctrough levels recorded within the reported therapeutic ranges of reference adalimumab trough levels (5-8 µg/ml) in RA patients. The safety profile among the three treatment groups was comparable, with the most common treatment-emergent adverse event (TEAE) being neutropenia and similar proportions seen across all treatment groups experiencing at least one TEAE: injection site reactions, hypersensitivity/allergic reactions and infections. Anti-drug antibody (ADA) and neutralising antibody (NAb) results were also similar among the three treatment groups; the proportions of patients who had ADA/NAbs were 28.4%/24.8% in CT-P17 maintenance, 27.0%/24.3% in reference adalimumab maintenance and 28.3%/26.3% in switched to CT-P17 groups.

Professor Jonathan Kay of the University of Massachusetts Medical School and Principal Investigator of the trial said, “CT-P17 is administered at 100 mg/mL, reflecting the high-concentration formulation of reference adalimumab, and is also citrate-free, which could lessen discomfort during injection. Demonstration of equivalent efficacy and comparable safety of CT-P17 to EU-sourced adalimumab in this study supports the ongoing clinical evaluation of CT-P17 as an adalimumab biosimilar.”

Celltrion are also pleased to announce that the European Commission (EC) has granted marketing authorisation for Remsima^® SC (infliximab) to be used without IV infusion both for new and existing RA patients.³ The EC approval follows a positive Committee for Medicinal Products for Human Use (CHMP), of the European Medicines Agency (EMA), opinion issued for direct use of subcutaneous therapy without IV loading in adults with RA in March 2021.

“Celltrion now has biosimilars of both infliximab and adalimumab with value-added features, and thus CT-P17 could be used sequentially with Remsima^® SC to bring clinical benefit for chronic diseases which require long- term treatment,” said Dr. HoUng Kim, Ph.D., Head of Medical and Marketing Division at Celltrion Healthcare. “Having both Remsima^® SC and Yuflyma™ in our product pipeline furthers our efforts to deliver value-added medicines to both payers and patients.”

– ENDS –

Notes to Editors:

About CT-P17 (biosimilar adalimumab)

CT-P17 is the first proposed high-concentration, low-volume and citrate-free adalimumab biosimilar. CT-P17 is indicated for the treatment of patients with rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritis (pJIA), enthesitis-related arthritis (ERA), ankylosing spondylitis (AS), axial spondyloarthritis without radiographic evidence of AS (nr-axSpA), psoriatic arthritis (PsA), psoriasis (PsO), paediatric plaque psoriasis (pPsO), hidradenitis suppurativa (HS), Crohn’s disease (CD), paediatric Crohn’s disease (pCD), ulcerative colitis (UC), uveitis (UV) and paediatric uveitis (pUV). CT-P17 is a recombinant human monoclonal antibody that contains the active ingredient adalimumab. Adalimumab is a fully human anti–tumour necrosis factor ? (anti-TNF-?) monoclonal antibody. CT-P17 provides pain-reducing features as it has a citrate-free formulation, meaning it causes less pain upon injection.

About Remsima^® CT-P13 subcutaneous (SC) formulation^4,5

A 120 mg fixed dose of Remsima^® SC has been granted marketing authorisation in the EU, in adults regardless of body weight, in all previously approved indications for the IV formulation. Remsima^® SC has three administration options; via a pre-filled pen (auto injector), pre-filled syringe or pre-filled syringe with needle safeguard. The SC formulation has the potential to enhance treatment options for the use of infliximab biosimilar by providing high consistency in drug exposure and a convenient method of administration.

About Celltrion Healthcare

Celltrion Healthcare is committed to delivering innovative and affordable medications to promote patients’ access to advanced therapies. Its products are manufactured at state-of-the-art mammalian cell culture facilities, designed and built to comply with the US FDA cGMP and the EU GMP guidelines. Celltrion Healthcare endeavours to offer high-quality cost-effective solutions through an extensive global network that spans more than 110 different countries. For more information please visit: https://www.celltrionhealthcare.com/en-us.

References

¹ Ann Rheum Dis, volume 80, supplement 1, year 2021, page 1123

² Furst D, et al. Efficacy and Safety after Transition from Reference Adalimumab to CT-P17 (Adalimumab Biosimilar: 100mg/mL) in comparison with the Maintained Treatment (CT-P17 or Reference Adalimumab) in Patients with Moderate-to-Severe Active Rheumatoid Arthritis: 1-Year Result. Abstract 325. Presented at EULAR 2021.

³ European Medicines Agency Summary of Product Characteristics (SmPC) Available at https://www.ema.europa.eu/en/documents/product-information/remsima-epar-product-information_en.pdf [Last accessed May 2021].

⁴ Yoo DH, Jaworski J, Matyska-Piekarska E et al. A Novel Formulation of CT-P13 (infliximab biosimilar) for subcutaneous administration: One-year results from part one of a Phase I/III randomised controlled trial in patients with rheumatoid arthritis. Poster (FRI0128). Presented at EULAR 2019.

⁵ Westhovens R, Wiland P, Zawadzki M et al. A novel formulation of CT-P13 (infliximab biosimilar) for subcutaneous administration: 30-week results from part two of a Phase I/III randomised controlled trial in patients with rheumatoid arthritis. Poster (SAT0170). Presented at EULAR 2019.

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