• CT-P17 is the first biosimilar with high concentration (100mg/mL) and citrate-free formulation
• 24-week data has shown comparable efficacy and safety data for adalimumab biosimilar CT-P17 against reference adalimumab in rheumatoid arthritis (RA)¹
• Comparable pharmacokinetics (PK) and safety data was also presented for CT-P17 in comparison with EU-approved adalimumab and US-licensed adalimumab in healthy subjects²

INCHEON, South Korea--(BUSINESS WIRE)--New data to be presented at the American College of Rheumatology (ACR) Convergence 2020 demonstrate that the efficacy, pharmacokinetics (PK) and overall safety of CT-P17, a proposed high concentration (100mg/mL) and citrate-free adalimumab biosimilar, is comparable to reference adalimumab in the treatment of rheumatoid arthritis (RA) patients.

The randomised, double-blind, phase III study investigated the equivalence of CT-P17 to reference adalimumab in terms of efficacy, pharmacokinetics (PK) and overall safety over 24 weeks.¹ 648 patients with active moderate-to-severe RA despite methotrexate (MTX) treatment were randomly assigned to receive 40mg of CT-P17 or reference adalimumab every 2 weeks up to week 24.

Results demonstrated CT-P17 has equivalent efficacy to reference adalimumab - the ACR20 response rate at week 24 was 82.7% (268/324) for both CT-P17 and reference adalimumab. Similar additional secondary efficacy endpoints were seen in terms of ACR20/50/70 response rates, mean DAS28 (CRP), clinical disease activity index (CDAI) and simplified disease activity index (SDAI) and EULAR (CRP) response. The PK results in terms of mean C_trough of adalimumab up to week 24 were slightly higher for CT-P17 and the mean C_trough was generally lower in the anti-drug antibody (ADA) positive subgroup than the ADA negative subgroup in both treatment groups. The safety profile of CT-P17 up to week 24 was comparable to that of the reference adalimumab as the majority of events were grade 1 or grade 2 in intensity.¹

�These phase III results show a comparable PK, efficacy and safety profile between CT-P17 and the reference adalimumab, building on evidence demonstrating that CT-P17 is equivalent to reference adalimumab for the treatment of rheumatoid arthritis�, said Professor Edward Keystone, Senior Consultant Rheumatologist, Mount Sinai Hospital, Toronto, Canada. �These promising study results support the use of CT-P17, the first adalimumab biosimilar with high concentration and citrate-free formulation as an alternative option for eligible patients with rheumatoid arthritis.�

Further data presented by Celltrion Healthcare at ACR Convergence 2020 investigated the PK and safety of CT-P17 in comparison to EU-approved adalimumab (EU- adalimumab) and US- licensed adalimumab (US- adalimumab) in healthy subjects up to 10 weeks. In this phase I, randomised, double-blind, single-dose study, 312 healthy subjects aged 19 to 55 years were randomised in a 1:1:1 ratio to receive either CT-P17, EU- adalimumab or US- adalimumab after a single subcutaneous (SC) injection of 40mg (100mg/mL). The results showed that the 90% confidence intervals (CI) for the geometric least squares mean ratio of each of the primary PK parameters (AUC_0-inf, AUC_0-last, and C_max) were within the predefined equivalence margin of 80% to 125%. The overall safety profile was comparable, and the number of subjects who had positive ADA and neutralising ADA (NAb) results were also similar among the three treatment groups.²

Celltrion Healthcare also presented PK and safety data for two delivery methods for CT-P17, the auto-injector (AI) and pre-filled syringe (PFS). As part of the study, 193 healthy subjects were randomly split into two groups to receive 40mg of either CT-P17 AI or CT-P17 PFS. Following a single SC administration of CT-P17 via AI, mean peak and total systemic exposure (AUC_0-inf, AUC_0-last and C_max) were equivalent with those of CT-P17 PFS, which indicates that CT-P17 AI could be a viable alternative administration option.³

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Notes to editors:

About CT-P17 (biosimilar adalimumab)

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 indicated for the treatment of patients with rheumatoid arthritis (RA), psoriatic arthritis (PsA), ankylosing spondylitis (AS), Crohn�s disease (CD), ulcerative colitis (UC), psoriasis (PsO), hidradenitis suppurativa (HS), uveitis (UV) and juvenile idiopathic arthritis (JIA). CT-P17 is the first proposed high concentration (100mg/mL) adalimumab biosimilar with citrate-free formulation, meaning it causes less pain upon injection.

A phase I randomised, double-blind, three-arm, single-dose study demonstrated PK and safety equivalence of CT-P17 to the high concentration (100mg/mL), citrate-free formulation of both US- and EU- sourced reference adalimumab in healthy subjects.² A phase III randomised, double-blind study demonstrated the equivalence efficacy to CT-P17 at week 24 to reference adalimumab in patients with moderate-to-severe active rheumatoid arthritis.¹ A phase I, randomised, open-label, parallel group, single-dose study demonstrated PK equivalence of CT-P17 auto-injector (AI) and pre-filled syringe (PFS) in healthy subjects.³

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 endeavors 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

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References

¹ J. Kay., et al. (2020). A Randomized, Double-Blind, Phase 3 Study to Compare the Efficacy and Safety of a Proposed High Concentration (100 mg/mL) Adalimumab Biosimilar (CT-P17) with Reference Adalimumab in Patients with Moderate-to-Severe Active Rheumatoid Arthritis. Poster Presented at ACR Convergence 2020.

² Yu KS, et al. (2020). Pharmacokinetics and Safety of CT-P17, a Proposed High Concentration (100 mg/mL) Adalimumab Biosimilar, in Comparison with EU-Approved Adalimumab and US-Licensed Adalimumab; Results of a Phase 1, Randomized, Double-blind, Three-arm, Single-dose Study in Healthy Subjects. Poster Presented at ACR Convergence 2020.

³ E. Keystone, et al. (2020). A Phase 1, Randomized, Open-label, Parallel Group, Single-dose Study to Compare the Pharmacokinetics and Safety of the Auto-injector and Pre-filled Syringe of CT-P17, a Proposed, Higher Concentration Biosimilar (100 mg/mL) Adalimumab, in Healthy Subjects. Poster Presented at ACR Convergence 2020.

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